BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933521 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03825
    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
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH CONSTANT MOTOR ERROR LOOP DURING REWIND DUE TO JAMMED MOTOR GEARBOX. UNABLE TO PERFORM DISPLACEMENT TEST DUE TO MOTOR ERROR. CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHED LCD WINDOW NOTED.

    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 REPORTED RECEIVING A MOTOR ERROR ON THE INSULIN PUMP. CUSTOMER STATED THAT THE MOTOR ERROR OCCURRED DURING A RESERVOIR CHANGE. HE COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THIS ALARM AND STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO ANY STRONG MAGNETIC FIELD OR MRI. CUSTOMER WAS ASSISTED WITH CLEARING THE ALARM BUT WAS STILL UNABLE TO REWIND THE INSULIN PUMP. THE BLOOD GLUCOSE READING WAS 182 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411047 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR