BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBGSTAR BGMS

    MDR report key: 3779153 · Received April 22, 2014

    Report

    Report Number
    3004637226-2014-00015
    Event Type
    Injury
    Date Received
    April 22, 2014
    Date of Event
    March 21, 2014
    Report Date
    April 18, 2014
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K103544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER. CONFIRMATION TESTING FOUND THE METER OPERATES WITHIN SPECIFICATION. TEST STRIPS FROM LOT IM07WE08F WERE RETURNED WITH THE METER. IT IS ASSUMED THESE TEST STRIPS WERE USED AT THE TIME OF THE EVENT. THIS TEST STRIP LOT EXPIRED 31 JAN 2013. A REVIEW OF THE OWNER'S GUIDE WAS PERFORMED. IT EXPLICITLY DIRECTS THE USER NOT TO TEST WITH EXPIRED TEST STRIPS AND THAT DOING SO MAY PRODUCE INACCURATE RESULTS. BASED ON THE RETURNED METER OPERATING WITHIN SPECIFICATION, WE BELIEVE THE ROOT CAUSE OF THE INCIDENT WAS FROM THE USE OF EXPIRED TEST STRIPS.

    Description of Event or Problem · 1

    THE PATIENT MENTIONED THE IBGSTAR PRODUCED BLOOD-GLUCOSE RESULTS GREATER THAN 4 G/L. SHE HAD ADJUSTED HER DOSAGE OF NOVORAPID IN RESPONSE TO THIS (FROM 8 IU TO 11 IU). SHE THEN EXPERIENCED HYPOGLYCEMIA WITH BLOOD-GLUCOSE VALUES OF 0.67 AND 0.48 G/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244067 IBGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-05716

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other