BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512WWL PRDGM INSULIN CL EN

    MDR report key: 1060255 · Received June 11, 2008

    Report

    Report Number
    2032227-2008-00968
    Event Type
    Injury
    Date Received
    June 11, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 28, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS, AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE CUSTOMER EXPERIENCED A HIGH BLOOD GLUCOSE READING OF 500 MG/DL. THE CUSTOMER WAS HOSPITALIZED AND THE BLOOD GLUCOSE READING WENT DOWN TO 250 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP DID NOT PASS THE SELF TET. IT WAS STATED THAT THE INSULIN PUMP HAD A LOW BATTERY ALARM. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512WWL PRDGM INSULIN CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512WWL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization