BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1163092 · Received September 15, 2008

    Report

    Report Number
    2939301-2008-02243
    Event Type
    Injury
    Date Received
    September 15, 2008
    Report Date
    May 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 REC'D 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 THE DISPLAY ON HER ONCETOUCH ULTRA METER WAS FADING. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PT ON THE FOLLOWING MONTH AND OBTAINED THE FOLLOWING INFO. THE PT CONFIRMED THE REPORTED ISSUE BEGAN A FEW DAYS PRIOR TO CONTACTING LFS. WHEN SHE FIRST NOTICED THE DISPLAY FADING, THE PT CLAIMED SHE REPLACED THE BATTERY. WHEN THE NEW BATTERY DID NOT RESOLVE THE ISSUE, THE PT MENTIONED SHE THEN CONTACTED LFS. THE PT DOES NOT RECALL IF SHE MADE ANY SPECIFIC CHANGES TO HER DIABETES TREATMENT AS A RESULT OF THE REPORTED ISSUE. THE PT IS ON AN INSULIN PUMP AND REPORTEDLY TESTS HER BLOOD GLUCOSE 9-10 TIMES/DAY, BECAUSE HER READINGS FLUCTUATE A LOT. SOMETIME AFTER THE REPORTED ISSUE BEGAN (DATE/TIME UNKNOWN), THE PT BECAME "THIRSTY" AND FELT AS IF HER BLOOD GLUCOSE WAS RUNNING HIGH. SINCE THE PT DID NOT HAVE A BACKUP METER OF HER OWN, SHE TESTED ON HER MOTHER-IN-LAW'S ONETOUCH ULTRA METER. THE PT DOES NOT RECALL THE ACTUAL RESULT OBTAINED, BUT CONFIRMED IT WAS A HIGH READING. THE PT CLAIMED SHE PROCEEDED WITH TAKING ADDITIONAL INSULIN (TYPE AND DOSE UNKNOWN) AS A RESULT OF THE HIGH READING OBTAINED OF THAT METER THAT CORRELATED WITH HOW SHE FELT. THE PT DENIES SEEKING MEDICAL INTERVENTION FROM A HEALTHCARE PROFESSIONAL AS A RESULT OF THE ALLEGED ISSUE. DURING TROUBLESHOOTING, THE CCA WAS ABLE TO CONFIRM THERE WAS NO MISUSE TO THE SUBJECT METER. THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PT. THIS COMPLAINTS IS BEING REPORTED BECAUSE THE PT CLAIM SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2792792

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening| R