BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAB PRDGM ISN V2.2 BL EN

    MDR report key: 940362 · Received November 9, 2007

    Report

    Report Number
    3004209178-2007-00566
    Event Type
    Injury
    Date Received
    November 9, 2007
    Date of Event
    October 25, 2007
    Report Date
    October 25, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    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 CURRENT KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER'S HUSBAND CALLED TO REPORT THAT THE CUSTOMER HAD ACCIDENTALLY PRIMED A LARGE AMOUNT OF INSULIN INTO HER BODY. HE STATED THAT THE CUSTOMER INSERTED THE RESERVOIR INTO THE INSULIN PUMP WHILE BEING CONNECTED. HE ALSO STATED SHE DIDN'T REWIND THE INSULIN PUMP PRIOR TO INSERTING THE RESERVOIR. IT WAS THEN STATED ON ANOTHER PHONE CALL THAT THE CUSTOMER HAD BEEN HOSPITALIZED FOR LOW BLOOD GLUCOSE DUE TO THE ACCIDENTAL PRIME. NO BLOOD GLUCOSE READING WAS REPORTED. THE CUSTOMER STATED HER MEDICAL DOCTOR HAS PLACED HER BACK ON THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAB PRDGM ISN V2.2 BL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization