BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTO UP&UP BGMS

    MDR report key: 4748870 · Received May 4, 2015

    Report

    Report Number
    3004637226-2015-00016
    Event Type
    Injury
    Date Received
    May 4, 2015
    Report Date
    April 30, 2015
    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 METER WAS REQUESTED AND HAS BEEN RETURNED TO THE MFR. 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 METER READINGS NOR INSULIN DOSED WAS NOT PROVIDED. THE METER DATE AND TIME WAS NOT SET. THIS CAUSED MANY OF THE READINGS TO BE STAMPED WITH THE INCORRECT DATE AND TIME. BASED ON THE LIMITED INFO PROVIDED, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. SOME FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT INCLUDE: ENVIRONMENTAL, MEDICAL OR TESTING CONDITIONS. INSULIN MAY HAVE CONTRIBUTED TO THE EVENT. NO REMEDIAL ACTION WILL BE INITIATED BECAUSE SYSTEM FAILURE COULD NOT BE CONFIRMED. THIS EVENT WILL CONTINUE TO BE TRENDED.

    Description of Event or Problem · 1

    THE REPORTER ALLEGES THE PRESTO UP&UP METER MEASURED HER BLOOD-GLUCOSE TOO HIGH COMPARED TO HER SYMPTOMS. THE READINGS FROM THE UP&UP METER ARE ENTERED INTO HER INSULIN PUMP. THE REPORTER ALLEGES THE PRESTO UP&UP METER READ 130, 113, 126 MG/DL WHILE SHE WAS EXPERIENCING SYMPTOMS SHE CLAIMS WERE INDICATIVE OF THE LOW 60'S. SHE REPORTED ADMINISTERING 2X THE DOSE OF AN UNSPECIFIED MEDICINE AND FELT BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291755 PRESTO UP&UP BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-04799 LS12WJ48J

    Patients

    Seq Age Sex Outcome Treatment
    1 Other