BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5981095 · Received September 27, 2016

    Report

    Report Number
    2032227-2016-19916
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    March 9, 2016
    Report Date
    September 30, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED FUNCTIONAL TESTING INCLUDING SELF-TEST, A21 ERROR TEST, DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, OFF NO POWER TEST AND EXCESSIVE NO DELIVERY TEST. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. THE INSULIN PUMP WAS PROGRAMMED WITH TEST GLUCOSE METER AND COMMUNICATED PROPERLY AND RECORDED THE 75MG/DL VALUE PROPERLY FROM GLUCOSE METER. THE INSULIN PUMP HAD CRACKED RESERVOIR TUBE LIP, CRACKED CASE AT THE DISPLAY WINDOW CORNER, BROKEN BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS, CRACKED CASE, MISSING THE END CAP STICKER AND MINOR SCRATCHED DISPLAY WINDOW.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SCRATCHES ON THE SCREEN. THE CUSTOMER REPORTED THAT THEY COULD NOT READ THE SCREEN ANYMORE. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THE INSULIN PUMP MIGHT HAVE BEEN BUMPED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632355 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR