BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRUETRACK

    MDR report key: 1754002 · Received July 9, 2010

    Report

    Report Number
    1052693-2010-00027
    Event Type
    Other
    Date Received
    July 9, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 9, 2010
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). HAVE CONTACTED CUSTOMER AND (B) (6) FOR ADD'L INFO AND PRODUCT RETURN. PHARMACIST STATED METER WAS ALREADY PACKAGED FOR RETURN, WE DID NOT GET A SERIAL NUMBER FOR THE METER YET. THE STRIP LOT NUMBER IS RK3161. CUSTOMER STATED SHE WAS USING THESE SAME STRIPS WITH THE NEW METER AND STRIPS ARE WORKING FINE.

    Description of Event or Problem · 1

    CLAIM RECEIVED FROM (B) (6) ON BEHALF OF CUSTOMER. CLAIMANT STATES THAT PER THE CUSTOMER, THE TRUETRACK SYSTEM MIS-READ THE BLOOD SUGAR LEVEL AND THE BLOOD SUGAR DROPPED TOO LOW. AMBULANCE WAS CALLED TO THE USER'S RESIDENCE, WHERE THE PT WAS STABILIZED. THE PT WAS NOT TRANSPORTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RK3161

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention