BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1890148 · Received October 29, 2010

    Report

    Report Number
    3004209178-2010-83252
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 21, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 447 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE BOLUS HISTORY, BASAL, DATES, TIME, AND DAILY TOTALS WERE CORRECT. THE ALARM HISTORY REVEALED NO DELIVERY AND WEAK BATTERY ALARM. RAN A FIXED PRIME AND HIGH PRESSURE TESTS AND THE INSULIN PUMP PASSED THE TESTS. THE CUSTOMER MENTIONED HAVING A CRACK ON HER DEVICE NEAR THE BATTERY CAP THREADS. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization