BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515NAL PRDGM INS V2.1 CL EN

    MDR report key: 1050266 · Received May 22, 2008

    Report

    Report Number
    2032227-2008-00874
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 10, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K0406776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY CALLED TO REPORT AN ALARM ON THE INSULIN PUMP. THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE. NO BLOOD GLUCOSE READING WAS REPORTED. NO FURTHER INFO ABOUT THE HOSPITALIZATION WAS PROVIDED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USING THE INSULIN PUMP AS IT NEEDED TO BE REPLACED DUE TO THE ALARMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization