BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982090 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06099
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TESTS. THE DEVICE WAS PROGRAMMED WITH MULTIPLE BOLUSES AND MONITORED. THE BOLUSES WERE DELIVERED AND RECORDED PROPERLY IN THE BOLUS HISTORY SCREEN. NO BOLUS HISTORY ANOMALY NOTED. THE UNIT HAD CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEIR INSULIN PUMP STOPPED DELIVERING INSULIN FOR THE PAST COUPLE OF WEEKS. THE CUSTOMER'S BLOOD GLUCOSE WAS 400 MG/DL AND WAS NOT TREATED. THE CUSTOMER STATED THAT THEY HAVE A BACK-UP PLAN. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP WAS NOT RECORDING THE BOLUS. WHEN CHECKING THE HISTORY OF THE DEVICE, IT WAS NOTED THAT THE LAST TWO BOLUSES WERE NOT RECORDED. WHILE TROUBLESHOOTING FOR THE HIGH BLOOD GLUCOSE, IT WAS NOTED THAT THE DATE AND THE TIME WERE PROGRAMMED INCORRECTLY IN THE INSULIN PUMP. ASSISTANCE WAS PROVIDED TO CORRECT THE ISSUE. ALSO, FOUND NO DELIVERY ALARM IN THE ALARM HISTORY OF THE INSULIN PUMP. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456577 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR