BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAP PRDGM INS V2.2 PL EN

    MDR report key: 1810093 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-82490
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 24, 2010
    Report Date
    July 24, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED AND TREATED WITH INSULIN DRIP FOR HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 661MG/DL. IT WAS STATED THAT THE NURSE CANNOT VERIFY IF SETTINGS ON THE INSULIN PUMP WERE CORRECT. TROUBLESHOOTING WAS PERFORMED. RAN A FIXED PRIME AND HIGH PRESSURE TESTS AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization