BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRUE2GO

    MDR report key: 2519763 · Received March 30, 2012

    Report

    Report Number
    1052693-2012-00005
    Event Type
    Other
    Date Received
    March 30, 2012
    Date of Event
    March 14, 2012
    Report Date
    March 30, 2012
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN COMMUNICATION WITH CONSUMER. STILL ATTEMPTING TO GET PRODUCT BACK.

    Description of Event or Problem · 1

    RECEIVED INITIAL EMAIL FROM (B)(6) ABOUT A CONSUMER WHO PURCHASED THE PRODUCT AND INSULIN FOR HER DAUGHTER. WE SPOKE WITH CONSUMER SUBSEQUENTLY. ACCORDING TO THE CONSUMER, SHE CHECKED HER DAUGHTER'S BLOOD SUGAR (328 MG/DL) AFTER A MEAL, AND THEN ADMINISTERED INSULIN. THE CONSUMER PERFORMED ANOTHER GLUCOSE TEST AT 10:30PM (114 MG/DL). THESE WERE THE ONLY TWO TESTS PERFORMED. AT 1:30AM, THE DAUGHTER WAS HAVING A SEIZURE. EMS WAS CONTACTED AND THE EMS METER GAVE RESULT OF 28 MG/DL. DAUGHTER WAS TAKEN TO THE HOSPITAL AND RELEASED AT 4 AM. CUSTOMER BELIEVES TRUE2GO GAVE A HIGH RESULT. CUSTOMER STATES SHE WILL RETURN PRODUCT ONLY AFTER COMPENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUE2GO BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUE2GO TM2050

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization