BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAP PRDGM INS V2.1 PL EN

    MDR report key: 1140170 · Received August 27, 2008

    Report

    Report Number
    3004209178-2008-00664
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    July 25, 2008
    Report Date
    August 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. 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

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO HYPOGLYCEMIA. THE CUSTOMER STATED THAT THE CAUSE OF THE EVENT WAS OVER EXERTION AFTER RETURNING FROM VACATION. DURING THE PHONE CALL, THE CUSTOMER ALSO COMPLAINED OF RECEIVING MOTOR ERROR ALARMS ON THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED, AND THE DISPLACEMENT AND SELF TESTS WERE RUN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAP PRDGM INS V2.1 PL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization