BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE RESULT

    MDR report key: 4959506 · Received July 30, 2015

    Report

    Report Number
    1052693-2015-01290
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 28, 2015
    Manufacturer
    INPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". MS. (B)(6) CALLED ON FOR HER SON, SHE STATES SHE RAN A BLOOD TEST ON HER SON WITH THE METER AND IT SAID "LO". HER SON HAS BEEN UNRESPONSIVE SINCE (B)(6) 2015. CUSTOMER SAY SHE WAS PUTTING JUICE IN HIS MOUTH AND HE WAS FEELING SLEEPY AND LOST COLOR. HER SON HAS BEEN UNRESPONSIVE SINCE (B)(6) 2015. CUSTOMER WAS UNSURE OF WHAT TO DO NEXT. IT WAS ADVISED THAT SHE IMMEDIATELY SEEK MEDICAL ATTENTION AND CALL 911.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495663 TRUE RESULT BLOOD GLUCOSE SYSTEM NBW INPRO DIAGNOSTICS, INC. TRUE RESULT PP1203

    Patients

    Seq Age Sex Outcome Treatment
    1 Other