BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 2070205 · Received April 18, 2011

    Report

    Report Number
    2032227-2011-00959
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS OVER 440 MG/DL. THE CUSTOMER ALSO EXPERIENCED EXCESSIVE THIRST AND VOMITING. THE CUSTOMER HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS FOR THE PAST MONTH AS WELL. TROUBLESHOOTING WAS PERFORMED, AND FOUND THAT THE INSULIN PUMP HAD GIVEN AN ALARM THAT ERASED ALL OF THE BASAL RATES. ALSO FOUND SEVERAL NO DELIVERY ALARMS IN THE ALARM HISTORY. THE INSULIN PUMP PASSED THE LEAD SCREW AND SELF TESTS, BUT THERE WAS NO TUBING CLAMP FOR THE HIGH PRESSURE TEST. A TUBING CLAMP WAS SENT TO THE CUSTOMER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508LUC

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization