BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1834305 · Received September 14, 2010

    Report

    Report Number
    2939301-2010-07925
    Event Type
    Injury
    Date Received
    September 14, 2010
    Report Date
    September 9, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K001109.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 ON (B)(6) 2010 ALLEGING AN ERROR 2 MESSAGE ON HIS ONE TOUCH ULTRA METER. THE PATIENT MENTIONED THAT THE REPORTED ISSUE BEGAN ON THE MORNING OF (B)(6) 2010. THE PATIENT DOES NOT TAKE ANY DIABETES MEDICATION. AT AN UNSPECIFIED TIME LATER AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF FEELING SHAKY AND WEAK. THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. THE PATIENT WAS USING THE CORRECT TEST STRIPS. THE METER WOULD NOT POWER ON BY PRESSING THE M BUTTON. PATIENT USED A NEW VIAL OF TEST STRIPS AND THE ISSUE WAS RESOLVED. PRODUCTS WERE REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE ALLEGED ERROR 2 MESSAGE ON HIS METER AND LATER DEVELOPED SYMPTOM SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2922027

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening