BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4150331 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-35047
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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 REPORTS TO HAVE RECEIVED SEVERAL INSULIN PUMP MALFUNCTIONS. CUSTOMER STATES SHE RECEIVED NO DELIVERY ALARM, BATTERY OUT LIMIT ALARMS WHICH ALARMS DURING REGULAR USE AND EXCESSIVE MOTOR ERROR ALARMS. CUSTOMER STATES ALARMS HAPPENS AFTER INFUSION SET CHANGE AND RESERVOIR CHANGE. CUSTOMER'S BLOOD GLUCOSE WAS 324 MG/DL WHICH WAS TREATED WITH MANUAL INJECTION. DURING TROUBLESHOOT; CUSTOMER RECEIVED SEVERAL MOTOR ERROR ALARMS AT REWIND. CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629223 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR