BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1142760 · Received August 27, 2008

    Report

    Report Number
    2939301-2008-01941
    Event Type
    Injury
    Date Received
    August 27, 2008
    Report Date
    August 20, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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

    ON AUGUST 20, 2008 THE LAY USER/REPORTER (PATIENT'S DAUGHTER) CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONETOUCH ULTRA METER HAD A BATTERY INDICATOR MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT TESTS HER BLOOD GLUCOSE THREE TIMES A DAY AND MANAGES HER DIABETES WITH DIET AND EXERCISE ONLY. APPROXIMATELY TEN DAYS AGO SOMETIME IN THE MORNING, THE PATIENT MENTIONED THAT THE SUBJECT METER "TURNED ON BUT HAD A BATTERY INDICATOR MESSAGE". AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY DID NOT DO ANYTHING DIFFERENT IN TERMS OF HER DIABETES MANAGEMENT. THE PATIENT REPORTEDLY COULD NOT TEST DUE TO THE BATTERY INDICATOR MESSAGE. SOMETIME AFTER THE ALLEGED METER ISSUE BEGAN, THE PATIENT STATED THAT SHE DEVELOPED SYMPTOMS OF "SHAKY, HUNGRY, AND HAD DRY MOUTH" BUT REPORTEDLY DID NOT SEEK FOR MEDICAL INTERVENTION OR RECEIVED ANY TREATMENT. DURING TROUBLESHOOTING, THE CSR VERIFIED THE FOLLOWING: THE PATIENT HAS JUST REPLACED THE BATTERY. THIS WAS NOT A NEW OUT OF BOX PRODUCT. THE CORRECT TEST STRIPS WERE USED. THE METER DID POWER ON WHEN THE POWER BUTTON WAS PRESSED AND WHEN THE TEST STRIP WAS INSERTED ALL THE WAY INTO THE TEST STRIP PORT. THE PATIENT'S PRODUCTS HAVE BEEN REPLACED. THE COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE PATIENT CLAIMED THAT SHE COULD NOT TEST DUE TO THE ALLEGED ISSUES 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 2840275

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening