BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4211838 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44855
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO ERROR ALARMS OCCURRED DURING TESTING. THE INSULIN PUMP PASSED THE RESET ERROR TEST AND THE SELF TEST. THE INSULIN PUMP HAD MULTIPLE ALARMS IN THE ALARM HISTORY DUE TO A CORRUPTED HISTORY FILE. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND A CRACKED RESERVOIR TUBE LIP.

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A SERIES OF ALARM ON THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 201 MG/DL. THE CUSTOMER STATED THAT SHE WAS UNABLE TO RESET THE ALARM AND INSULIN PUMP RESET ITSELF. THE TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED TO MONITOR THE INSULIN PUMP AND CALL IF THE ISSUES RECCUR. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692078 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR