BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUERESULT

    MDR report key: 3084526 · Received April 25, 2013

    Report

    Report Number
    1052693-2013-00063
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 25, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT¿S MOTHER CALLED TO COMPLAIN THAT THE TRUE RESULT WAS READING TOO HIGH AND WAS DIRECTLY RESPONSIBLE FOR THE REQUIRED MEDICAL INTERVENTION. TESTED DAUGHTER. TRUE RESULT METER RESULTS WAS 454 MG/DL. MOTHER ADMINISTERED INSULIN. MOTHER COULD NOT PROVIDE INFO REGARDING THE TYPE OR AMOUNT OF INSULIN. USING ANOTHER METER, THE MOTHER TESTED THE DAUGHTER¿S BLOOD 30 MINUTES LATER. METER RESULT WAS 149 MG/DL. STATES THAT DAUGHTER BECAME INCREASINGLY LETHARGIC AND UNRESPONSIVE, SO CALLED FOR AN AMBULANCE. DAUGHTER WAS ADMITTED TO THE HOSPITAL FOR DIABETIC COMA. MOTHER IS NOT AWARE OF DAUGHTER¿S GLUCOSE LEVEL AT TIME OF ADMITTANCE TO HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178230 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT TN2372

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization