BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2061559 · Received April 18, 2011

    Report

    Report Number
    2939301-2011-03151
    Event Type
    Injury
    Date Received
    April 18, 2011
    Report Date
    April 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRAMINI METER HAD A CRACKED DISPLAY. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. IT IS NOT KNOWN WHEN THE ALLEGED ISSUE BEGAN. THE CCA WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE. LESS THAN A DAY AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED HE FELT SYMPTOMS OF SWEATY AND HOT. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER HAD BEEN RUN OVER BY A CAR. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2969605

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening