BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAS PRDGM INS SK EN ML

    MDR report key: 1161654 · Received September 15, 2008

    Report

    Report Number
    2032227-2008-01599
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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

    THE CUSTOMER STATED THAT HE WAS CONNECTED DURING THE MANUAL PRIME AND INADVERTENTLY DELIVERED THE ENTIRE RESERVOIR OF INSULIN INTO HIS BODY. EMERGENCY MEDICAL SERVICES WERE CALLED TO TREAT THE CUSTOMER, BUT THE CUSTOMER DECLINED TO BE TREATED OR TAKEN TO THE HOSPITAL. DURING THE PHONE CALL, THE PARAMEDICS WERE TRYING TO CONVINCE THE CUSTOMER TO RECEIVE TREATMENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAS PRDGM INS SK EN ML INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention