BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715RNAS PRDGM INS SK EN ML PR

    MDR report key: 1222025 · Received November 3, 2008

    Report

    Report Number
    2032227-2008-01898
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    October 11, 2008
    Report Date
    October 11, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 STATED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE READ "HIGH" ON THE GLUCOMETER. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE DISPLACEMENT AND SELF TESTS. THE CUSTOMER STATED THAT HE WAS GOING TO THE HOSPITAL FOR ASSISTANCE TREATING HIS HIGH BLOOD GLUCOSE LEVELS. AFTER THE INITIAL PHONE CALL, THE CUSTOMER'S WIFE CALLED BACK AND CONFIRMED THAT THE CUSTOMER HAD BEEN HOSPITALIZED DUE TO HYPERGLYCEMIA. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715RNAS PRDGM INS SK EN ML PR INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization