BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 5072109 · Received September 11, 2015

    Report

    Report Number
    2032227-2015-43151
    Event Type
    Death
    Date Received
    September 11, 2015
    Date of Event
    September 6, 2015
    Report Date
    February 17, 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

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST. THE INSULIN PUMP RECEIVED WITH NO BATTERY INSTALLED. THE INSULIN PUMP RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW AND CRACKED BATTERY TUBE THREADS. DATA ANALYSIS: THERE IS NO DATA LISTED FOR THE DATED OF (B)(6) 2015 DUE TO INSULIN PUMP RECEIVED WITHOUT BATTERY INSTALLED.

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY FAILURE ANALYSIS THAT WAS NOT INCLUDED ON THE INITIAL DEVICE EVALUATION: THE INSULIN PUMP PASSED THE DISPLACEMENT ACCURACY TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN A HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2015. THE CAUSE OF DEATH WAS HEART ATTACK - CARDIAC ARREST. THE CUSTOMER HAD KIDNEY DISEASE. THE CALLER STATED THAT THEY WERE NOT SURE WHAT THE CUSTOMER'S BLOOD GLUCOSE WAS AT THE TIME OF PASSING, MAYBE 144 MG/DL. HOWEVER, IT WAS 180 MG/DL IN THE MORNING OF (B)(6) 2015. THE CALLER STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP WHEN HE WAS TAKEN TO THE HOSPITAL; HOWEVER, IT WAS DISCONNECTED BY HOSPITAL STAFF. THE CUSTOMER WAS PLACED ON INTRAVENOUS INSULIN DRIPS. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER DID NOT USE SENSORS AND WAS NOT WEARING ONE AT THE TIME OF DEATH. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604074 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death