BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712RNAB PRDGM INS BL EN US RC

    MDR report key: 1810100 · Received August 16, 2010

    Report

    Report Number
    2032227-2010-82350
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 17, 2010
    Report Date
    July 17, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO CARDIAC ARREST. WHILE IN THE HOSPITAL, THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE FLUCTUATING BETWEEN 54 AND 500 MG/DL. THE HOSPITAL STAFF ASSURED THE CUSTOMER THAT THE INSULIN PUMP WAS FUNCTIONING CORRECTLY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712RNAB PRDGM INS BL EN US RC INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization