Product Manual

11447475 160
25 test strips
1 code strip
Accutrend Plus
Accu-Chek
®
InstantPlus
For use in the USA only
This is a CLIA Waived test system. A Certificate of CLIA Waiver (or higher)
is required to perform the test. Information on obtaining CLIA certificates
can be found at www.cms.hhs.gov/clia. Facilities performing testing must
have a CLIA Certificate of Waiver. 42USC263a(c)(2).
Laboratories with a certificate of waiver must follow the manufacturer’s
instructions for performing the test. 42CFR493.15(e)(1). Any modifications
and/or failure to follow test system instructions, including those for
limitations/intended use and performance of QC testing as a failure alert
mechanism, results in use that is considered high complexity and subject to
all applicable CLIA requirements. All applicable state and local laws must
be met.
Any adverse reactions experienced with the use of this product, and/or
quality problems should also be reported to the FDA’s MedWatch Adverse
Event Reporting program online (at www.fda.gov/MedWatch/report.htm), by
phone (1‑800‑FDA‑1088), or by returning the postage‑paid FDA form 3500
(which may be downloaded from www.fda.gov/MedWatch/getforms.htm) by
mail to (MedWatch, 5600 Fishers Lane, Rockville, MD 20852‑9787) or fax
(1‑800‑FDA‑1078).
Intended use
Accutrend Glucose test strips are for the quantitative determination of
glucose in capillary whole blood. For use by health care professionals and
for home use by people with diabetes for glucose testing.
For use with AccutrendPlus and Accu‑ChekInstantPlus meters. Before
using these test strips read this method sheet and the User’s Manual
carefully.
For in vitro diagnostic use
Patient information
Introduction
Almost anyone with diabetes can be helped by self-testing of blood glucose.
Under a doctor’s care, self-testing can help you achieve near-normal blood
glucose levels.
The Accutrend Glucose test strip, used as directed with an AccutrendPlus
or Accu‑ChekInstantPlus meter, will accurately measure your blood
glucose level. The strip changes color as it reacts to glucose in a drop of
blood and the meter measures this color change. Your total blood glucose
is then displayed on the meter display screen.
Product updates
This section of your package insert may contain new information that has
not yet been included in the AccutrendPlus or Accu‑ChekInstantPlus
User’s Manuals. Refer to this section each time you get a new container of
test strips for the latest revisions or updates.
Reagent handling
▪ Tightly re‑cap the container immediately after removing a test strip.
Exposure to light and moisture may discolor the test strips which may
lead to an error code.
▪ Do not cut or alter the test strips in any way. This will lead to an error
code.
Storage and stability
▪ Store strips at 36‑86°F(2‑30°C). Do not freeze.
Tips for getting a good drop of blood
AccutrendPlus and Accu‑ChekInstantPlus meters and strips require a
hanging drop of blood. If you are new to self testing, or have had trouble
getting enough blood in the past, you may want to review the following
steps before you proceed with testing.
▪ Wash hands in warm, soapy water; rinse and dry completely. Warming
the fingers can help increase blood flow. If you use an alcohol wipe to
clean your finger, make sure the finger is completely dry before
continuing.
▪ Let your arm hang down at your side briefly to allow blood to flow to
fingertips.
▪ Grasp finger near area to be pricked and squeeze for three seconds.
▪ Keeping hand down, prick side of fingertip, and squeeze gently until you
get a hanging drop of blood. For lancing the finger RocheDiagnostics
recommends Accu‑ChekSoftclix, Accu‑ChekSafe‑T‑Pro and
Accu‑ChekSafe‑T‑ProPlus devices.
Understanding your glucose test result
What’s normal?
The normal fasting adult blood glucose range for a non-diabetic is
70‑105mg/dL.
1
One or two hours after meals, normal blood glucose levels
should be less than 140mg/dL.
2
Your health care provider will determine
the range that is appropriate for you.
What if I get a low blood sugar reading?
If LO is displayed, your blood glucose result may be below 20mg/dL. You
may also observe symptoms of low blood glucose. If these symptoms—
sweating, trembling, blurred vision, rapid heart beat, tingling or numbness
around the mouth or fingertips are present— seek proper treatment
immediately. If they are absent, YOU SHOULD REPEAT THE TEST. Be
sure to check the test strip visually with the color chart on the container to
confirm the test result.
If you repeat the test and obtain a low result again, contact your physician
immediately. Always, contact your physician before you change your
therapy.
What if I get a high blood sugar reading?
If HI is displayed, your blood glucose result may be higher than 600mg/dL.
Be sure to check the test strip visually with the color chart on the container
to confirm the test result.
Caution
If your blood glucose value is high (above 240mg/dL) for several days, your
kidneys may excrete large amounts of water, causing excessive urination
and dehydration. Dehydration may result in a glucose reading that is lower
than the true value. We recommend that you contact your doctor if your
glucose remains above 240mg/dL for several days. If your blood glucose
level is above 240mg/dL, you should monitor your urine ketone levels with
ChemstripK or ChemstripuGK test strips. Contact your doctor immediately
if you detect moderate or high ketone levels, or if you experience thirst,
abdominal pain, vomiting, difficulty in breathing or headaches. If you get an
unusual test result, review the testing procedures. Repeat the test with a
new test strip. If your blood glucose value still does not reflect your physical
condition, contact your physician.
Unusual test results
If your blood glucose value seems unusually high or low, and does not
reflect the way you feel, there may be problems with your test procedure,
test strip or meter, or the test strip code number may not match the code
number on the meter. The following can cause unusually high or low
results:
▪ Test strip was used after expiration date.
▪ Test strip was not stored in container with cap tightly sealed.
▪ Test strip was stored in extreme temperatures.
▪ Meter was not properly maintained or handled.
▪ Meter was not properly coded for the strips being used.
▪ Blood drop was too small.
If you get an unusual test result, review the testing procedures. Repeat the
test with a new test strip. If your blood glucose value still does not reflect
your physical condition, contact your physician.
Return policy
If you have a problem with your Accutrend Glucose test strips, you may be
asked to return them, with the code strip, to Roche Diagnostics. Before
returning, call Technical Support at 1‑800‑440‑3638. You will be mailed a
return authorization label which must be put on your shipping carton.
Cartons received without this label will be returned to you at your expense.
Limitations of procedure
The limitations of the Accutrend Glucose test strips are listed in the Health
care professional information section of this method sheet. Please read the
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