BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    MDR report key: 1851611 · Received September 28, 2010

    Report

    Report Number
    3004209178-2010-82921
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN 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 AND TREATED WITH AN INSULIN DRIP FOR HIGH BLOOD GLUCOSE OF 498 MG/DL. THE CUSTOMER STATED THAT HER HEALTH CARE PROFESSIONAL THINKS THE TYPE OF INSULIN THE CUSTOMER USES MIGHT HAVE CONTRIBUTED TO HER HIGH GLUCOSE LEVEL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY SEVERAL TIMES. THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE DEVICE PASSED THE TESTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAP PRDGM INS V2.2 PL EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization