BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAS PRDGM INS SK EN ML

    MDR report key: 1821185 · Received August 26, 2010

    Report

    Report Number
    2032227-2010-82451
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE INSULIN PUMP HAD A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS, WITH A READING OF 60 MG/DL. THE CUSTOMER WAS DRIVING WHEN HIS ALERT DOG BEGAN TO BARK. THE CUSTOMER HAD NOT DELIVERED A BOLUS SINCE THE MORNING, AND HE FELT THAT HIS BASAL RATES OR CALIBRATION MAY HAVE CAUSED THE EVENT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, AND THE RESERVOIR VOLUME WAS ACCURATE. THE CUSTOMER DID NOT FEEL SAFE WITH THE INSULIN PUMP AND ASKED TO HAVE IT REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAS PRDGM INS SK EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization