BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3951372 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-88084
    Event Type
    Death
    Date Received
    July 22, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH DEPLETED ALKALINE BATTERY INSIDE THE BATTERY TUBE. THE INSULIN PUMP PASSED DISPLACEMENT TEST. UNABLE TO PRIME AND MOTOR ERROR ALARMED DURING BASIC OCCLUSION TEST. UNABLE TO DETERMINE ROOT CAUSE DUE TO INSULIN PUMP PRESERVATION. UNABLE TO PERFORM OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TEST DUE TO PRIME ANOMALY. CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, SCRATCHED DISPLAY WINDOW AND SCRATCHED CASE NOTED DURING VISUAL INSPECTION.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH DEPLETED ALKALINE INSIDE THE BATTERY TUBE. INSULIN PUMP PASSED DISPLACEMENT TEST. UNABLE TO PRIME AND MOTOR ERROR ALARMED DURING BASIC OCCLUSION TEST. UNABLE TO DETERMINE ROOT CAUSE DUE TO INSULIN PUMP PRESERVATION. INSULIN PUMP WAS UNABLE TO PERFORM OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TEST DUE TO PRIME ANOMALY. INSULIN PUMP HAD A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, SCRATCHED DISPLAY WINDOW AND SCRATCHED CASE NOTED DURING VISUAL INSPECTION. INSULIN PUMP WAS UNABLE TO PRIME AND MOTOR ERROR ALARMED DURING BASIC OCCLUSION TEST DUE TO MOISTURE DAMAGE NOTED IN FORCE SENSOR. INSULIN PUMP HAD A CORRODED MOTOR HOME SWITCH ALSO NOTED. DRIED INSULIN ON MOTOR SLIDE NOTED. NO MOISTURE DAMAGE NOTED ON ELECTRONIC ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY. CAUSE OF THE DEATH WAS REPORTED TO BE COMPLICATIONS FROM DIABETES. IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO CONTROL HER DIABETES. THE CUSTOMER WAS REPORTED TO BE OFF THE INSULIN PUMP FOR 24 HOURS PRIOR TO THE DEATH. THE INSULIN PUMP WAS REQUESTED TO BE SENT BACK. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428450 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death