BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-522RNAB PRDGM INS BL EN RC

    MDR report key: 1729587 · Received June 15, 2010

    Report

    Report Number
    2032227-2010-81501
    Event Type
    Death
    Date Received
    June 15, 2010
    Date of Event
    May 23, 2010
    Report Date
    May 25, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. 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 PASSED AWAY DURING NECK SURGERY. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF HER DEATH, AND WAS EXPERIENCING BLOOD GLUCOSE LEVELS ABOVE 600 MG/DL. THE CUSTOMER WAS IN A LOT OF PAIN, AND WANTED TO DIE, SO SHE WAS GIVEN MEDICATION FOR HER PAIN. THE CUSTOMER HAD ATTEMPTED TO CONTROL HER BLOOD GLUCOSE LEVELS WITH THE INSULIN PUMP AND WITH MANUAL INJECTIONS TO NO AVAIL. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522RNAB PRDGM INS BL EN RC INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death