FDA Adverse Event Injury Summary report: N

FREESTYLE GLUCOSE TEST STRIPS

MDR report key: 1940121 · Received December 22, 2010

Report

Report Number
MW5018704
Event Type
Injury
Date Received
December 22, 2010
Report Date
December 22, 2010
Manufacturer
ABBOTT
Product Code
LFR
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I STARTED USING AN OMNIPOD INSULIN PUMP ON (B)(6) 2010. IT USES FREESTYLE TEST STRIPS FOR GLUCOSE TESTING BY ABBOTT. AFTER USING THE STRIPS FOR 3 MONTHS, I HAD A HEMOGLOBIN A1C BLOODTEST ON (B)(6) 2010. THE READING WAS 7.8, A RAISE OF ALMOST 1 POINT. I SAW DOCTOR ON DEC 2. MY BLOOD SUGAR READINGS WERE NOT CONSISTENT WITH THE RAISE IN THE A1C TEST. HE ADVISED ME TO TEST MY BLOOD WITH ANOTHER METER AND THE ONE USING THE FREESTYLE STRIPS BECAUSE MY READINGS LOOKED GOOD BUT MY A1C SHOULD NOT BE THAT HIGH. I WENT TO DOCTOR AGAIN ON (B)(6) 2010. THEY OPENED A NEW ONE TOUCH METER AND TESTED MY BLOOD WITH BOTH METERS. THE FREESTYLE STRIPS WERE 200 POINTS LOWER THAN THE NEW ONE TOUCH METER. MY BLOOD SUGARS WERE RUNNING ALMOST 500 AND I WAS SHOWING MODERATE KETONES IN MY URINE. I CALLED INSULET COMPANY THAT MAKES THE OMINPOD AND THEY KNEW THE STRIPS WERE NOT WORKING, BUT I RECEIVED NO LETTER WARNING OF THIS. I AM NOW USING THE ONE TOUCH METER, MY DOCTOR GAVE ME, AND MANUALLY ENTERING MY BLOOD SUGARS INTO THE INSULIN PUMP. I TEST MY BLOOD 5-8 TIMES A DAY. I SEE MY DIABETES DOCTOR EVERY THREE MONTHS UNLESS I HAVE A PROBLEM. I ALSO FAX MY READINGS TO HIM EVERY 2 WEEKS OR GO TO HIS OFFICE AND DOWNLOAD THE READINGS FROM MY INSULIN PUMP. I SAW THE REPORTS ON THE TV NEWS, BUT THERE WAS NO MENTION OF THE FREESTYLE STRIPS. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: TO TEST BLOOD GLUCOSE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 FREESTYLE GLUCOSE TEST STRIPS NONE LFR ABBOTT 1021019

Patients

Seq Age Sex Outcome Treatment
1 61 YR Life Threatening