BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUETRACK

    MDR report key: 2383693 · Received December 15, 2011

    Report

    Report Number
    1052693-2011-00066
    Event Type
    Injury
    Date Received
    December 15, 2011
    Date of Event
    December 1, 2011
    Report Date
    December 14, 2011
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEVICE IS ALLEGED TO BE DEFECTIVE, WITH NO FURTHER DESCRIPTION AS TO THE TYPE OF DEFECT. EVENT DESCRIBED AS SERIOUS, PERMANENT, ADVERSE HEALTH CONSEQUENCES, WITH NO FURTHER DESCRIPTION. DATE OF ACTUAL EVENT UNK. THE DEVICE WAS PURCHASED AND DELIVERED TO THE PT IN 2009.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability