BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1163088 · Received September 15, 2008

    Report

    Report Number
    2939301-2008-02262
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, 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 STIRPS 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/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA METER HAD A "BATTERY INDICATOR ISSUE." THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION SINCE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO CONTACT THE PT TO OBTAIN ADDITIONAL INFO. THE MAS MAILED A LETTER TO THE PT ON SEPTEMBER 12, 2008. THE PT STATED THAT THE REPORTED ISSUE BEGAN A COUPLE OF DAYS PRIOR TO CONTACTING LFS (DATE AND TIME NOT SPECIFIED). THE PT REPORTEDLY WAS GETTING A "BATTERY ICON" ON THE SUBJECT METER DURING THAT TIME. ON ORIGINAL DATE AT 10 AM, AFTER THE REPORTED ISSUE BEGAN, HE REPORTEDLY FELT SYMPTOMS OF "HIGH BLOOD SUGAR." THE PT REPORTEDLY COULD NOT TEST ON THE SUBJECT METER DUE TO THE REPORTED ISSUE. THE PT REPORTEDLY TOOK NO DIABETES TREATMENT ACTIONS FOLLOWING THE ISSUE AND DID NOT RECEIVE/REQUIRE ANY MEDICAL TREATMENT OR INTERVENTION FOR THE DIABETES. THE PT WAS NOT TESTED ON ANY OTHER METER. DURING THE TROUBLESHOOTING, IT WAS NOTED THAT THIS WAS NOT A NEW PRODUCT AND THE PT NEVER REPLACED THE BATTERIES (USER-ERROR) PER THE OWNER'S MANUAL. REPLACEMENT PRODUCTS WERE SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT REPORTEDLY EXPERIENCED SYMPTOMS OF HYPERGLYCEMIA AFTER THE REPORTED ISSUE AND REPORTEDLY COULD NOT CONFIRM THE RESULTS ON THE SUBJECT METER DURING THE SYMPTOMS. IN ADDITION, THERE IS NO EVIDENCE THAT THE METER MALFUNCTIONED SINCE DURING THE TROUBLESHOOTING; IT WAS FOUND OUT THAT THE PT NEVER REPLACED THE BATTERIES (USE-ERROR) PER THE OWNER'S MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2834457

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening