BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2086112 · Received May 11, 2011

    Report

    Report Number
    2939301-2011-03933
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 6, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K061118. LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ALLEGING A BATTERY INDICATOR ON THEIR ONE TOUCH ULTRAMINI METER. THE PATIENT MENTIONED THAT THE REPORTED ISSUE BEGAN ON (B)(6) 2011 AT AROUND 6:00AM. DUE TO THE ALLEGED ISSUE, THE PATIENT WAS UNABLE TO TEST THEIR BLOOD GLUCOSE. APPROXIMATELY A COUPLE OF HOURS LATER THE PATIENT DEVELOPED SYMPTOMS OF FEELING SHAKY. THE PATIENT NOT SEEK MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THIS IS NOT THE FIRST TIME THE PRODUCT IS BEING USED. THERE WAS NO MISUSE OF THE PRODUCT. THE METER DID NOT NEED REPLACEMENT BATTERIES. ISSUE WAS NOT RESOLVED OVER THE PHONE AND THE METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE BATTERY INDICATOR, THE PATIENT WAS UNABLE TO TEST AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening