BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 6044225 · Received October 20, 2016

    Report

    Report Number
    2032227-2016-33273
    Event Type
    Death
    Date Received
    October 20, 2016
    Date of Event
    October 4, 2016
    Report Date
    February 7, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TESTING INCLUDING THE IDLE CURRENT MEASUREMENT TEST, RUN CURRENT MEASUREMENT TEST, SELF- TEST, OFF NO POWER TEST, UNEXPECTED RESTART ERROR TEST, DISPLACEMENT TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, REWIND TEST AND EXCESSIVE NO DELIVERY TEST. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE AND STAINED END CAP STICKER. DATA ANALYSIS THERE IS NO DATA LISTED FOR THE DATED OF (B)(6) 2016 DUE TO PUMP RECEIVED WITHOUT BATTERY INSTALLED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN A HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2016. THE CALLER STATED THAT THE CAUSE OF DEATH IS STILL UNKNOWN. AFTER NOT SHOWING UP TO WORK FOR TWO DAYS SOMEONE WENT TO THE CUSTOMER'S HOME TO CHECK. THE CUSTOMER WAS FOUND ON (B)(6) 2016, STILL BREATHING BUT WAS UNCONSCIOUS. THE PARAMEDICS CHECKED THE CUSTOMER'S BLOOD GLUCOSE AND IT WAS 20 MG/DL. THE CALLER SATED THAT THE CUSTOMER'S BLOOD GLUCOSE, AT THE TIME OF DEATH, IS UNKNOWN. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH; IT WAS REMOVED AT THE EMERGENCY ROOM. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER STATES THAT THE CUSTOMER HAD KIDNEY TRANSPLANT IN 2011. THE CALLER AGREED RETURNING THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694216 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death