BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-722CAS PRDGM INS V2.2 SK EN PR

    MDR report key: 1852279 · Received October 1, 2010

    Report

    Report Number
    3004209178-2010-82977
    Event Type
    Death
    Date Received
    October 1, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 20, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    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 REPORTED VIA E-MAIL THAT THE CUSTOMER PASSED AWAY WHILE WEARING THE INSULIN PUMP. IT WAS STATED THAT THE MEDICAL EXAMINERS PRELIMINARY FINDINGS ARE INCONCLUSIVE AND NOTHING RELATED TO DIABETES. THE BLOOD GLUCOSE READING UPON FINDING THE BODY WAS 5MG/DL. IT WAS STATED THAT THE CUSTOMER WAS VERY STRESSED OUT FROM WORK. THE CUSTOMER WENT TO BED AND HIS BLOOD GLUCOSE WAS 3.8 MG/DL. THE CUSTOMER TREATED. THE NEXT DAY IN THE AFTERNOON HIS MOTHER WENT TO WAKE HIM UP AND HE WAS ALREADY DEAD. IT WAS STATED THAT HE WAS FOUND SURROUNDED BY EMPTY DEXTROSE TYPE CONTAINERS BUT NO SIGN OF MOVEMENT WHATSOEVER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722CAS PRDGM INS V2.2 SK EN PR INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722CAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death