BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1060290 · Received June 10, 2008

    Report

    Report Number
    2939301-2008-01048
    Event Type
    Injury
    Date Received
    June 10, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA METER WAS READING INACCURATE HIGH. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PT ON JUNE 9, 2008 AND OBTAINED THE FOLLOWING INFO. THE PT REPORTED THAT THE ALLEGED ISSUE STARTED ONE WEEK PRIOR TO CONTACTING LFS. ON THE MORNING OF ORIGINAL DAY, THE PT TESTED ON THE SUBJECT METER AND OBTAINED A READING OF "203 MG/DL" WHICH SHE CONSIDERED HIGH. THE PT CONFIRMED HER BLOOD GLUCOSE USUALLY RUNS BETWEEN "80-130MG/DL." AS A RESULT OF THE ALLEGED HIGH VALUE, THE PT THEN IMMEDIATELY TESTED ON HER HUSBAND'S ONETOUCH ULTRA2 METER AND OBTAINED A RESULT OF "146 MG/DL." BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PT ALSO REPORTED THAT ON AN UNSPECIFIED DATE/TIME, SHE HAD OBTAINED A READING OF "249 MG/DL" ON THE SUBJECT METER AND AS A RESULT TREATED HERSELF WITH HUMALOG INSULIN (PT DOES NOT RECALL THE NUMBER OF UNITS SHE GAVE HERSELF). AFTER ADMINISTERING THE INSULIN, THE PT TESTED ON HER HUSBAND'S METER AND OBTAINED A RESULT OF "180 MG/DL." SHORTLY THEREAFTER, THE PT CLAIMED SHE HAD "A LOW" AND DESCRIBED FEELING "DIZZY, WEAK, AND CLAMMY." AT THE TIME OF THESE SYMPTOMS SHE TESTED ON HER HUSBAND'S METER AND OBTAINED A READING IN THE "50'S." SHE RECALLS TREATING SELF WITH EITHER FOOD OR BEVERAGE AND FEELING BETTER AFTERWARDS. THE PT DENIED RECEIVING MEDICAL INTERVENTION FROM A HEALTHCARE PROFESSIONAL. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE PROPER UNIT OF MEASURE SETTING (MG/DL), THAT THE PT WAS USING THE CORRECT TESTING TECHNIQUE, AND THAT THE PUNCTURE AREA WAS BEING CLEANED PROPERLY. REPLACEMENT PRODUCTS WERE SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED, BECAUSE THE PT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED READING, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. IN ADDITION, THE SUBJECT METER DID NOT MEET LIFESCAN'S ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2785895

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R