BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTO UP&UP BGMS

    MDR report key: 5391900 · Received January 26, 2016

    Report

    Report Number
    3004637226-2016-00001
    Event Type
    Injury
    Date Received
    January 26, 2016
    Report Date
    January 26, 2016
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K073573
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER WAS REQUESTED AND HAS BEEN RETURNED TO THE MANUFACTURER. THE CONFIRMATION INVESTIGATION FOUND THE METER TO BE OPERATING WITHIN SPECIFICATION. THE TEST STRIP LOT DHR WAS REFERENCED AND THE LOT CLEARED QC FOR RELEASE. BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE DISCREPANT VALUES CANNOT BE DETERMINED. IT IS UNKNOWN HOW MUCH TIME ELAPSED BETWEEN THE COMPARISON OF THE TWO METERS. ENVIRONMENTAL CONDITIONS, TESTING PRACTICES AND MEDICAL CONDITIONS MAY HAVE CONTRIBUTED TO THE DISCREPANT READINGS. INSULIN MAY HAVE CONTRIBUTED TO THE EVENT. NO CORRECTIVE ACTION WILL BE IMPLEMENTED BECAUSE THE METER IS OPERATING WITHIN SPECIFICATION. THE INFORMATION ASSOCIATED WITH THIS EVENT WILL CONTINUE TO BE TRENDED.

    Description of Event or Problem · 1

    THE REPORTER STATES THE TARGET UP&UP METER IS TOO HIGH AND NOT CONSISTENT WITH HOW SHE IS FEELING. SHE PERFORMED TWO TESTS WITH THE TARGET METER (123, 126 MG/DL). THE CUSTOMER WAS FEELING SICK AS IF SHE WAS REALLY LOW. SHE THEN TESTED WITH HER BACK-UP MINI MED METER AND RECEIVED 48 MG/DL. TESTING PROCEDURE WAS REVIEWED AND THE CALLER IS TESTING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48743 PRESTO UP&UP BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-04799 MA02WS13G

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other