BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTO BGMS

    MDR report key: 3799713 · Received April 25, 2014

    Report

    Report Number
    3004637226-2014-00019
    Event Type
    Injury
    Date Received
    April 25, 2014
    Report Date
    April 24, 2014
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K073573
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER. THE CONFIRMATION INVESTIGATION FOUND NO FAULT WITH THE METER. THE TEST STRIP LOT DHR WAS REVIEWED AND PASSED QC TESTING. A REVIEW OF BOTH THE OWNER'S GUIDE AND SIMILAR COMPLAINTS WAS PERFORMED. MULTIPLE ATTEMPTS AT ACQUIRING MORE INFO FROM THE PATIENT WERE MADE WITH NO SUCCESS. THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED BASED ON THE LIMITED INFO PROVIDED.

    Description of Event or Problem · 1

    PATIENT TESTS AT 4AM, 7AM AND 7PM. HE TESTED IN THE MORNING AND REC'D A HIGH READING. HE DOSED 22 UNITS OF INSULIN AND SKIPPED LUNCH. HE TESTED IN THE EVENING, WAS VERY HUNGRY AND ALSO COMMENTED HE HAD HYPOGLYCEMIC SYMPTOMS. THE METER SHOWED 400 MG/DL. HE STATES THAT ANOTHER TIME, HE ATE LUNCH AND THE READING WAS LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250321 PRESTO BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-02661

    Patients

    Seq Age Sex Outcome Treatment
    1 Other