BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INSULIN CL EN

    MDR report key: 1133362 · Received August 22, 2008

    Report

    Report Number
    2032227-2008-01431
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 11, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE PASSED OUT DUE TO LOW BLOOD GLUCOSE. THE PARAMEDICS WERE CALLED OUT AND TREATED HIM. THE BLOOD GLUCOSE READING WAS 420 MG/DL. TROUBLESHOOTING WAS PERFORMED. RAN THE DISPLACEMENT TEST AND THE DEVICE PASSED THE TEST. THP PROGRAMMING WAS ACCURATE. RAN A FIXED PRIME TEST AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INSULIN CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention