BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1211570 · Received October 22, 2008

    Report

    Report Number
    2939301-2008-02741
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 28, 2008
    Report Date
    October 14, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCTS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF THE LFS PRODUCTS ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE LFS PRODUCTS 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) CANADA ALLEGING THAT THE ONE TOUCH ULTRAMINI METER HAS A POWER ISSUE (UNIT DOES NOT TURN ON). THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE FOLLOW-UP INFORMATION OBTAINED ON OCTOBER 16, 2008 AND THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE. ON THE PREVIOUS MONTH, THE PATIENT REPORTEDLY WENT TO THE GYM AND ATTEMPTED TO TEST HIS BLOOD GLUCOSE BUT COULD NOT POWER THE SUBJECT METER ON. THE PATIENT NORMALLY TESTS 3 TIMES WHILE AT THE GYM, TO ENSURE THAT HE'S NOT GOING TOO LOW. THE PATIENT CLAIMED THAT BECAUSE HE WAS UNABLE TO TEST, HE TOOK SOME "PREVENTATIVE" SIPS OF OJ, BUT IT WAS NOT ENOUGH TO COVER WHERE HIS BLOOD GLUCOSE REALLY WAS. REPORTEDLY, THE PATIENT DID NOT BOTHER TO TRY AGAIN TO TEST ON THE SUBJECT METER FOR THE OTHER TWO TESTS HE WOULD HAVE NORMALLY DONE. HIS REGULAR TESTING SCHEDULE IS TO TEST BEFORE STARTING, DURING, AND AFTER HIS EXERCISE ROUTINE. WHEN THE PATIENT GOT HOME PRIOR TO LUNCHTIME, HE HAD SYMPTOMS DESCRIBED AS "CONFUSED AND HAD HYPO SYMPTOMS." THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF "2.2 MMOL/L" ON A BACKUP METER AT THE TIME OF CONCERN. THE PATIENT TOOK ORANGE JUICE AND REPORTEDLY FELT BETTER. THE PATIENT FELT THAT HE DID NOT INGEST ENOUGH SUGAR TO GET HIM HOME WITHOUT GOING LOW. THUS, HAD THE METER GAVE A READING, HE WOULD HAVE DRUNK MORE OJ AND PREVENTED THE ALLEGED LOW GLUCOSE EPISODE. DURING TROUBLESHOOTING, THE REPORTED ISSUE WAS NOT RESOLVED. ALTHOUGH, THERE IS NO EVIDENCE OF PRODUCT MISUSE, THE BATTERY CONTACTS WERE IN GOOD CONDITION, AND THE BATTERY WAS REPLACED PER THE OWNER'S MANUAL, THE LFS METER DID NOT TURN ON WITH THE POWER BUTTON PRESSED AND THE TEST STRIP INSERTED INTO THE METER. THIS COMPLAINT BEING REPORTED BECAUSE THE PATIENT CLAIMED HE HAD SYMPTOMS THAT WERE SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE ON THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R