BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3942724 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04244
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS RECEIVED WITH AN A64 ALARM DURING SELF TEST DUE TO FAULTY CONNECTOR ON RADIO FREQUENCY. INSULIN PUMP HAD A MINOR SCRATCH ON LCD WINDOW, CRACKED DISPLAY WINDOW CORNER AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ALARM ON THE INSULIN PUMP. HE STATED THAT THIS ALARM OCCURRED DURING THE REWIND AND PRIME PROCESS. CUSTOMER WAS ADVISED TO REMOVE THE RESERVOIR AND PERFORM THE REWIND PROCESS AGAIN. HE WAS ADVISED TO PROGRAM A NORMAL BOLUS INTO THE AIR SO THAT THE BOLUS AMOUNT COULD BE RECORDED IN THE BOLUS HISTORY. THE BLOOD GLUCOSE READING WAS 175 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418213 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR