BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515LNAP PRDGM INS V2.1 PL EN

    MDR report key: 1142785 · Received August 27, 2008

    Report

    Report Number
    2032227-2008-01473
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 15, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER'S HUSBAND STATED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPOGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 73 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. IT WAS FOUND THAT THE INSULIN PUMP WAS READING THE RESERVOIR VOLUME ACCURATELY. IT WAS REPORTED THAT THE CUSTOMER HAD WALKED FOR MILES PRIOR TO THE EVENT. IT WAS ADVISED THAT THE CUSTOMER REVERT TO MANUAL INJECTIONS UNTIL A REPLACEMENT INSULIN PUMP COULD BE DELIVERED TO HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515LNAP PRDGM INS V2.1 PL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization