BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBGSTAR BGMS

    MDR report key: 4100739 · Received September 12, 2014

    Report

    Report Number
    3004637226-2014-00029
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 14, 2014
    Report Date
    September 11, 2014
    Manufacturer
    AGAMATRIX
    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 REQUESTED BUT HAS NOT BEEN RETURNED TO THE MANUFACTURER. THE REPORTED METER SERIAL NUMBER IS NOT VALID SO NO METER DHR WAS REFERENCED. THE TEST STRIP LOT DHR WAS REFERENCED AND THE LOT CLEARED QC FOR RELEASE. THE OWNER'S MANUAL WAS CAREFULLY REVIEWED. THERE IS NO INDICATION THE EVENT OCCURRED DUE TO POOR LABELING. AN ANALYSIS OF FIELD RETURNS REGARDING IBGSTAR METERS AND SIMILAR COMPLAINTS SHOWS NO ACCURACY ISSUES ATTRIBUTED TO METER MALFUNCTION HAVE BEEN CONFIRMED. THE TIMING OF THE THREE MEASUREMENTS ARE NOT GIVEN. BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE INCIDENT CANNOT BE DETERMINED. THIS COMPLAINT WILL BE TRENDED.

    Description of Event or Problem · 1

    THE WEEK PRIOR TO THE EVENT, THE CUSTOMER REPORTS OCCASIONALLY RECEIVING ERROR 7 ON TEST STRIP INSERTION. ON THE DATE OF THE EVENT, THE IBGSTAR METER READ 1.7 MMOL/L. THE CUSTOMER DID NOT FEEL HYPOGLYCEMIC, BUT DRANK SOME JUICE. BLOOD-SUGAR WAS MEASURED AGAIN AND THE IBGSTAR READ 20 MMOL/L. A THIRD MEASUREMENT WAS TAKEN, WHICH READ 2.9 MMOL/L. THE CUSTOMER FELT NEITHER HYPOGLYCEMIC NOR HYPERGLYCEMIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565070 IBGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX 8000-06958 KT21WP42D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other