BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTO BGMS

    MDR report key: 3865508 · Received May 29, 2014

    Report

    Report Number
    3004637226-2014-00022
    Event Type
    Injury
    Date Received
    May 29, 2014
    Report Date
    May 28, 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 NOT BEEN RETURNED TO THE MANUFACTURER. TEST STRIP LOT NUMBER KA11WJ65E DHR REFERENCED. THE LOT CLEARED QC TESTING. THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. A REVIEW OF THE OWNER'S GUIDE AND FIELD RETURNS HAVE BEEN MADE. CORRECTIVE ACTION IS NOT NECESSARY AT THIS TIME, AS THERE IS NO EVIDENCE OF DEVICE FAILURE. THIS COMPLAINT DESCRIPTION WILL BE TRENDED.

    Description of Event or Problem · 1

    PATIENT TESTED HER BLOOD-GLUCOSE AND THE PRESTO METER GAVE A HIGH READING. THE PATIENT FELT SHAKY, WHICH INDICATES A LOW BLOOD-GLUCOSE TO HER. SHE ATE SOMETHING BECAUSE SHE BELIEVED HER BLOOD-GLUCOSE TO BE LOW, DESPITE THE READING OF THE METER. SHE THEN WENT TO THE CLINIC AND THE PRESTO METER WAS COMPARED TO A BLOOD ANALYZER. THE ANALYZER SHOWED 180 MG/DL WHILE THE PRESTO METER READ 255 MG/DL. THE COMPARISON WAS PERFORMED A SECOND TIME, AND AGAIN THE PRESTO READ MORE THAN 75MG/DL HIGHER THAN THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317280 PRESTO BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-02661 KA11WJ65E

    Patients

    Seq Age Sex Outcome Treatment
    1 Other