BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBGSTAR BGMS

    MDR report key: 3767251 · Received April 4, 2014

    Report

    Report Number
    3004637226-2014-00013
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 3, 2014
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K103511
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MFR. THE METER WAS TESTED WITH IN HOUSE CONTROL SOLUTION AND TEST STRIPS SIX TIMES. NO TEST STRIP LOT INFO WAS PROVIDED. ALL RESULTS WERE WITHIN RANGE. A REVIEW OF BOTH THE OWNER'S GUIDE AND SIMILAR COMPLAINTS WAS PERFORMED. THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED BASED ON THE LIMITED INFO PROVIDED.

    Description of Event or Problem · 1

    ON SUNDAY, ON (B)(6) 2014, THE PT MEASURED HIS PREPRANDIAL BLOOD GLUCOSE TO BE HIGHER THAN 1 G/L AND ADJUSTED HIS DOSE OF NOVORAPID. THE PT BEGAN TO TREMBLE DURING THE MEAL AND HIS BLOOD-GLUCOSE MEASURED 0.4 G/L. ADDITIONAL CHECKS WERE NOT PERFORMED BECAUSE THE METER SHOWED ERROR 4. THE FIREFIGHTERS ALSO COULD NOT GET A READING WITH THEIR METER. AFTER THE PT TOOK SUGAR, HE BECAME HYPERGLYCEMIC WITH A BLOOD GLUCOSE OF 3 G/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205006 IBGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-05716

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other