BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4813519 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61819
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 13, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. THE OPERATING CURRENTS ARE WITHIN SPECIFICATION. NO OFF NO POWER LOW BATTERY ALARMS OR WEAK BATTERY ALERTS NOTED. THE INSULIN PUMP PASSED DISPLACEMENT, EXCESSIVE NO DELIVERY AND PRIME/A33 TESTS. NO UNEXPECTED NO DELIVERY ALARMS NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE LCD WINDOW, SCRATCHED ON THE CASE AND CRACKED BELT CLIP SLOT. ACT.

    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 VIA PHONE, THE DEVICE CONTINUES TO HAVE BATTERY ISSUES EVENT AFTER THE BATTERY CAP HAS BEEN CHANGED OUT TWICE. CUSTOMER'S BLOOD GLUCOSE WAS 97 MG/DL. THE DEVICE HAD ALARMED WEAK BATTERY, OFF NO POWER, AND BAD BATTERY. CUSTOMER DECLINED TO TROUBLESHOOT FOR WEAK BATTERY AND NO DELIVERY WASN'T PERFORMED DUE TO CUSTOMER REPORTED A PAST EVENT. OFF NO POWER TROUBLESHOOTING WAS PERFORMED. THE DEVICE WAS DROPPED OR BUMPED AND THE DRIVE SUPPORT CAP WAS NOT DAMAGED. SECOND TIME THE DEVICE ALARMED OFF NO POWER WITHOUT A LOW BATTERY WARNING. CUSTOMER REQUESTED THE DEVICE TO BE REPLACED AND WILL BE RETURNING THE DEVICE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356835 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR