BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933459 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03867
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 RECEIVING ALARMS ON THE INSULIN PUMP. CUSTOMER STATED THAT SHE RECEIVED A MOTOR ERROR ALARM WHILE ATTEMPTING TO DELIVER A BOLUS. SHE STATED SHE ALSO RECEIVED A NO DELIVERY ALARM BUT DECLINED TROUBLESHOOTING FOR THIS ALARM. THE BLOOD GLUCOSE READING WAS 286 MG/DL. SHE HAD NOT YET TREATED HERSELF FOR HIGH BLOOD GLUCOSE AT THAT TIME. SHE DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE MOTOR ERROR AND STATED THAT THE INSULIN PUMP HAD NOT BEEN EXPOSED TO A HIGH MAGNETIC FIELD OR MRI. CUSTOMER WAS ASSISTED IN CLEARING THE ALARM AND WAS ABLE TO REWIND THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411148 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR