BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522CAP PRDGM INS V2.2 PL EN PR

    MDR report key: 1873673 · Received October 13, 2010

    Report

    Report Number
    3004209178-2010-83087
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 8, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    CGA
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 15.8 MMOL/L. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND PROGRAMMING ON THE INSULIN PUMP WERE CORRECT. THE ALARM HISTORY REVEALED NO DELIVERY AND LOW RESERVOIR ALARMS. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE INSULIN PUMP PASSED THE TESTS SUCCESSFULLY. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization