BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAP PRDGM INS PL EN US LN

    MDR report key: 1190058 · Received October 6, 2008

    Report

    Report Number
    2032227-2008-01738
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 27, 2008
    Report Date
    September 27, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN 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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE. NO BLOOD GLUCOSE LEVEL WAS PROVIDED AT THE TIME OF THE CALL. TROUBLESHOOTING WAS PERFORMED AND FOUND THE INSULIN PUMP'S TIME WAS BEHIND APPROXIMATELY 4-5 HOURS. THE CUSTOMER WAS ADVISED OF THE IMPORTANCE OF HAVING ACCURATE TIME. PERFORMED THE DISPLACEMENT TEST AND PASSED. AT THE END OF THE CALL CUSTOMER MENTIONED THAT SHE WAS IN A CAR ACCIDENT IN 2008, DUE TO LOW BLOOD GLUCOSE AND HOSPITALIZED FOR A COUPLE OF DAYS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512LNAP PRDGM INS PL EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization