BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTO KROGER BGMS

    MDR report key: 5046255 · Received September 1, 2015

    Report

    Report Number
    3004637226-2015-00031
    Event Type
    Injury
    Date Received
    September 1, 2015
    Date of Event
    August 2, 2015
    Report Date
    September 1, 2015
    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 DEVICE HAS BEEN REQUESTED AND HAS BEEN RETURNED TO THE MANUFACTURER. CONFIRMATION TESTING SHOWS THE METER TO BE OPERATING WITHIN SPECIFICATION. THE TEST STRIP LOT DHR WAS REFERENCED AND THE LOT CLEARED QC FOR RELEASE. THE OWNER'S GUIDE AND PREVIOUS FIELD RETURNS HAVE BEEN REVIEWED. THERE IS NO EVIDENCE FROM PREVIOUS FIELD RETURNS THE EVENT WAS CAUSED BY A METER MALFUNCTION. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED THOUGH INSULIN, OTHER MEDICATION, AND DIET MAY HAVE BEEN A CAUSE. FACTORS SUCH AS HEMATOCRIT, TEMPERATURE, HUMIDITY, ELEVATION, AND TESTING PROCEDURE MAY HAVE CONTRIBUTED TO A POTENTIALLY HIGHER READING. NO CORRECTIVE ACTION WILL BE PERFORMED BECAUSE NO SYSTEM ERROR CAN BE CONFIRMED. THIS EVENT WILL CONTINUE TO BE TRENDED.

    Description of Event or Problem · 1

    THE REPORTER ADMINISTERED AN INCREASED DOSE OF INSULIN BASED ON THE FASTING MEASUREMENT (255 MG/DL) OF THE KROGER METER. THE REPORTER FELT THE METER READING WAS INDICATIVE OF HIS SYMPTOMS. THE PATIENT INCREASED HIS INSULIN DOSE BASED ON THE MEASUREMENT AND ATE SCRAMBLED EGGS. THE PATIENT LATER PASSED OUT WHILE WAITING AT THE BUS STATION. THE EMTS TOOK HIM TO THE HOSPITAL WHERE HE WAS RELEASED THE NEXT DAY. HE WAS TREATED WITH A GLUCOSE IV AND FELT MUCH BETTER UPON DISCHARGE. A BLOOD-GLUCOSE MEASUREMENT UPON ADMISSION TO THE HOSPITAL WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577913 PRESTO KROGER BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-04166 MJ06WN85L

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O