BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 3951264 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-87919
    Event Type
    Death
    Date Received
    July 22, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    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. AN ATTEMPT WAS MADE TO CONTACT THE CUSTOMER'S NEXT OF KIN AND A REQUEST TO RETURN THE DEVICE WILL BE MADE IF CONTACT CAN BE MADE. FURTHER INFORMATION WILL FOLLOW ONCE AN ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH DEPLETED ENERGIZER ALAKALINE BATTERY INSTALLED. INSULIN PUMP PASSED THE FUNCTIONAL TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND SELF TEST. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. OFF NO POWER ALARM FUNCTIONS PROPERLY. NO FAILED BATTERY TEST ALARM NOTED. SMALL CRACK ON THE RESERVOIR TUBE LIP NOTED.

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS PROVIDED IN RESPONSE TO YOUR REQUEST DATED DECEMBER 17, 2014 FOR ADDITIONAL INFORMATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED THAT THE BLOOD GLUCOSE AT THE TIME OF DEATH WAS UNKNOWN. SHE STATED THAT THE CUSTOMER WAS HOME ALONE AND HAD JUST EATEN AND THAT SHE HAD TALKED TO HIM ABOUT ONE HOUR BEFORE HE WAS FOUND. THE LAST BLOOD GLUCOSE READING RECORDED IN THE INSULIN PUMP WAS 83 MG/DL. THE CAUSE OF DEATH WAS HEART ATTACK. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. SHE STATED THAT THE INSULIN PUMP WAS REMOVED AT THE HOSPITAL AND THAT WHEN SHE RECEIVED IT FROM THEM, IT HAD A FAILED BATTERY ALARM. SHE REPORTED THAT HE WAS A BRITTLE DIABETIC AND OFTEN HAD HIGHS AND LOWS. SHE REPORTED THAT HE WAS IN A CAR ACCIDENT ON (B)(6), 2004. SHE STATED THAT THE ACCIDENT WAS CAUSED BY LOW BLOOD GLUCOSE, BUT DID NOT KNOW THE CUSTOMER'S EXACT BLOOD GLUCOSE LEVEL AT THE TIME OF THE ACCIDENT. SHE STATED THAT THE CUSTOMER'S PROBLEMS REALLY STARTED WITH THAT ACCIDENT. NOTHING FURTHER WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY. AN ATTEMPT WAS MADE TO CONTACT THE CUSTOMER'S NEXT OF KIN IN ORDER TO OBTAIN ADDITIONAL DETAILS PERTAINING TO THE PASSING OF THE CUSTOMER BUT CONTACT WAS UNSUCCESSFUL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428302 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death