BEUDAMED
    FDA Adverse Event Summary report: N

    PUMP MMT-712LNAP PRDGM INS PL EN US LN

    MDR report key: 1080220 · Received July 18, 2008

    Report

    Report Number
    2032227-2008-01257
    Date Received
    July 18, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 355 MG/DL. TROUBLESHOOTING WAS PERFORMED. ALSO, THE CUSTOMER REPORTED THAT THE PUMP ALARMED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712LNAP PRDGM INS PL EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization