BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 4210377 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-37976
    Event Type
    Death
    Date Received
    October 25, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TOT HE 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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    NO BLOOD GLUCOSE LEVELS WERE PROVIDED. IT WAS REPORTED THAT THE CUSTOMER DIED ON (B)(6) 2014. THE FUNERAL DIRECTOR AT THE FUNERAL HOME WHERE THE CUSTOMER'S BODY WAS LYING REPORTED THE DEATH OF THE CUSTOMER. THE DIRECTOR ASL REPORTED THAT THE INSULIN PUMP WAS COVERED IN BLOOD BORNE PATHOGENS AND WAS CONTAMINATED. AN INQUIRY WAS MADE WHETHER OR NOT THE INSULIN PUMP SHOULD BE RETURNED TO THE FAMILY SINCE IT WAS CONTAMINATED. IT APPEARED THAT THE CUSTOMER'S FAMILY WAS REQUESTING THAT THE INSULIN PUMP BE RETURNED BECAUSE THEY MIGHT BE CHARGED FOR THE INSULIN PUMP IF THEY DO NOT RETURN IT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680633 530G INSULIN PUMP OZO MEDTRONIC PUERTO RICO OPERATIONS CO MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death