BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6514343 · Received April 22, 2017

    Report

    Report Number
    3004209178-2017-46324
    Event Type
    Malfunction
    Date Received
    April 22, 2017
    Date of Event
    March 11, 2017
    Report Date
    April 14, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE IDLE CURRENT MEASUREMENT TEST, RUN CURRENT MEASUREMENT TEST, OFF NO POWER TEST, A21 ERROR TEST, DISPLACEMENT TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, REWIND TEST AND EXCESSIVE NO DELIVERY TEST. HOWEVER, THE INSULIN PUMP WAS UNABLE TO VIBRATE DURING SELF TEST DUE TO FAULTY VIBRATOR MOTOR. THE INSULIN PUMP WAS RECEIVED WITH NO BATTERY INSTALLED. NO COSMETIC DAMAGES WERE NOTED. DATA ANALYSIS: (B)(6) 2017 DAILY INSULIN TOTAL = 0U. (B)(6) 2017 DAILY INSULIN TOTAL = 0U. (B)(6) 2017 DAILY INSULIN TOTAL = 0U. (B)(6) 2017 DAILY INSULIN TOTAL = 0U. (B)(6) 2017 DAILY INSULIN TOTAL = 0U. (B)(6) 2017 DAILY INSULIN TOTAL = 0U. (B)(6) 2017 DAILY INSULIN TOTAL = 0U.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN A HOSPICE HOUSE ON (B)(6) 2017. THE CAUSE OF DEATH WAS CANCER. THE CALLER STATED THAT THIS WAS THE FOURTH ROUND SINCE SEVENTEEN MONTHS. THE CALLER STATED THAT THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH; IT HAD BEEN DISCONNECTED TEN TO ELEVEN DAYS PRIOR TO PASSING BECAUSE THE HOSPITAL DID NOT KNOW HOW TO OPERATE THE INSULIN PUMP. THE CALLER DID NOT KNOW THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF DEATH. HOWEVER, STATED THAT THE LAST KNOW BLOOD GLUCOSE VALUE WAS 121 MG/DL. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. PLEASE SEE SECTION H10 FOR ANALYSIS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295210 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR