BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4230595 · Received October 11, 2014

    Report

    Report Number
    2032227-2014-37085
    Event Type
    Malfunction
    Date Received
    October 11, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PATIENT

    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

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, OPERATING CURRENTS, SELF TEST, OFF NO POWER TEST, RESET ERROR TEST, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY ALARM TEST. NO BAD BATTERY ALARM WAS NOTED. THE LOW RESERVOIR ALARM FUNCTIONED PROPERLY DURING THE TEST. THE INSULIN PUMP WAS RECEIVED WITH CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE FILLED 1.8 VIAL RESERVOIR TO 180 UNITS AND WITHIN 5 MINUTES THEIR INSULIN SHOWED 88 UNITS. CUSTOMER STATED THAT THE INSULIN PUMP WAS TAKING TOO LONG TO HAVE DROPS COME OUT DURING PRIMING AND FILLING THE TUBING. TROUBLESHOOTING WAS DONE FOR RESERVOIR LEAK. CUSTOMER'S BLOOD GLUCOSE WAS 115 MG/DL. FOUND NO SIGNS OF LEAKS IN TUBING OF RESERVOIR. ASSISTED THE CUSTOMER TO PERFORM DISPLACEMENT TEST TWICE AND NO RESERVOIR APPEARED. INSULIN PUMP FAILED THE DISPLACEMENT TEST. CUSTOMER INSULIN NEEDS TO BE RETURNED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. CUSTOMER WANTED TO USE THE CURRENT INSULIN PUMP AND WILL MONITOR AND WILL CALL BACK IF ISSUE PERSISTS. CUSTOMER'S LAST BLOOD GLUCOSE WAS 186 MG/DL. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645593 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-523RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR