BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3924340 · Received July 9, 2014

    Report

    Report Number
    2032227-2014-03469
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE BASIC OCCLUSION TEST AND WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR. THE MOTOR PASSED MOTOR TEST. UNABLE TO PERFORM THE OCCLUSION TEST DUE TO PRIME ANOMALY. THE DEVICE WAS RECEIVED WITH CRACKED BATTERY TUBE THREADS, RESERVOIR TUBE, RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW AND MISSING END CAP STICKER.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE HAD UNEXPLAINED HIGH BLOOD GLUCOSE AND HER INSULIN PUMP DO NOT SEEM TO BE WORKING. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE HIGH-PRESSURE TEST TWICE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401832 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR