BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAB PRDGM INS V2.2 BL EN

    MDR report key: 1791792 · Received August 4, 2010

    Report

    Report Number
    3004209178-2010-82340
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    July 11, 2010
    Report Date
    July 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 INCLUDING THE DISPLACEMENT TEST. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS VOMITING, DEHYDRATED, AND HAS GASTROPARESIS. THE BLOOD GLUCOSE READING AT TIME OF HIS HOSPITALIZATION WAS 250 MG/DL. THE CUSTOMER'S BLOOD GLUCOSE AT TIME OF THE CALL WAS 81 MG/DL AND HE TREATED WITH A MANUAL INJECTION. THE BLOOD GLUCOSE INCREASED UP TO 220MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE SETTINGS IN THE DEVICE WAS CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TESTS AND PASSED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAB PRDGM INS V2.2 BL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization