BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715RNAS PRDGM INS SK EN ML PR

    MDR report key: 1192434 · Received October 7, 2008

    Report

    Report Number
    2032227-2008-01743
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 2, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    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 PROD 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 SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 538 MG/DL. THE CUSTOMER STATED THAT PRIOR TO THE EVENT, THE INSULIN PUMP ALARMED LOW RESERVOIR, AND SHE WAS UNABLE TO CLEAR THE ALARM. THE CUSTOMER STATED THAT SHE REMOVED THE INSULIN PUMP PRIOR TO BEING HOSPITALIZED. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE INSULIN PUMP HAD NOT COMPLETED THE PRIME PROCESS DUE TO THE BATTERY BEING DEPLETED. THE CUSTOMER WAS ADVISED TO CALL BACK TO PERFORM TROUBLESHOOTING WHEN A NEW BATTERY IS AVAILABLE. 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