BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712NAS PRDGM INSULIN SK EN

    MDR report key: 1161661 · Received September 15, 2008

    Report

    Report Number
    2032227-2008-01587
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 2, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA AND VOMITING. TROUBLESHOOTING WAS PERFORMED, AND IT WAS FOUND THAT THE INSULIN PUMP WAS SKIPPING SCREENS AND THE ACT BUTTON WAS UNRESPONSIVE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712NAS PRDGM INSULIN SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization