BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103606 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26459
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER INSULIN PUMP WAS REBOOTING AND THE BATTERY WAS NEEDING TO BE CHANGED AFTER ONE DAY. THE CUSTOMER STATED SHE CHANGED THE BATTERY ON (B)(6) 2014 AND RECEIVED A FAILED BATTERY TEST. SHE STATED SHE TOOK THE BATTERY OUT AND PUT IN ANOTHER AND GOT ANOTHER FAILED BATTERY ALARM. THE CUSTOMER THEN BOUGHT NEW BATTERIES AND STATED A BATTERY WORKED UNTIL THE NEXT MORNING, AT WHICH POINT IT SHOWED 3 BARS, BUT HAD RESET AND DEFAULTED TO FACTORY SETTINGS. THE SAME AFTERNOON, THE CUSTOMER RECEIVED A LOW BATTERY ALERT AND ALL OF THE BARS, WHICH INDICATE BATTERY LIFE, WERE GONE. SHE THEN PUT IN ANOTHER NEW BATTERY AND STATED AFTER THREE OR FOUR MINUTES, THE INSULIN PUMP TOTALLY SHUT DOWN AND CAME BACK UP. TROUBLESHOOTING WAS PERFORMED AND AFTER NO RELATED PHYSICAL ANOMALIES WITH THE INSULIN PUMP WERE FOUND AND IT WAS ADVISED TO INSERT A NEW BATTERY AND CLEAN THE BATTERY CAP CONTACTS, ANOTHER FAILED BATTERY TEST OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582539 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR