BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-522RNAB PRDGM INS BL EN RC

    MDR report key: 1667355 · Received April 23, 2010

    Report

    Report Number
    2032227-2010-80994
    Event Type
    Death
    Date Received
    April 23, 2010
    Date of Event
    April 2, 2010
    Report Date
    April 6, 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 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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE CUSTOMER PASSED AWAY AFTER EXPERIENCING A HYPOGLYCEMIC EVENT, WHILE WEARING THE INSULIN PUMP. IT WAS STATED THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE LEVELS BETWEEN 30 AND 40 MG/DL. THE CUSTOMER ATE 50 TO 60 CARBOHYDRATES, THEN GAVE A 17 UNIT BOLUS. THE CUSTOMER USED THE REAL TIME SYSTEM, BUT DID NOT CALIBRATE. IT WAS STATED THAT THE CERTIFIED INSULIN PUMP TRAINER WOULD BE DOWNLOADING THE INSULIN PUMP. 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 57 YR Death