BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    MDR report key: 1951850 · Received December 28, 2010

    Report

    Report Number
    3004209178-2010-83682
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 13, 2010
    Report Date
    December 14, 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 HYPOGLYCEMIA SEIZURE. THE BLOOD GLUCOSE READING WAS 63MG/DL. INITIALLY, THE NURSE CALLED FOR ASSISTANCE WITH INSERTING THE BATTERY INTO THE INFUSION PUMP. THE NURSE STATED THAT THE DEVICE ALARMED. ASSISTED THE NURSE IN CHANGING THE BATTERY. IT WAS STATED THAT THE CUSTOMER DOES NOT KNOW WHY HER GLUCOSE LEVEL DROPPED, BUT SHE HAD A SEIZURE AND PASSED OUT ON THE FLOOR. THE CUSTOMER'S BLOOD GLUCOSE WAS 55MG/DL AND WAS GIVEN SOME JUICE, BUT THE CUSTOMER STARTED TO THROW UP AND PARAMEDICS WERE CALLED. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE ON THE INSULIN PUMP WERE CORRECT. RAN A DISPLACEMENT TEST AND THE DEVICE PASSED THE TEST. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization