BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4990765 · Received August 11, 2015

    Report

    Report Number
    2032227-2015-26582
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 16, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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 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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD AN INTERMITTENT MOTOR ERROR ALARMS AND ALARM DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH NOTED. THE INSULIN PUMP WAS UNABLE TO PERFORM DISPLACEMENT TEST, REWIND TEST, BASIC OCCLUSION TEST, PRIME TEST, OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST DUE MOTOR ERROR ALARMS. THE INSULIN PUMP HAD A CRACKED LCD WINDOW, CRACKED CASE AT LCD WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW AND BROKEN BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AND REPORTED RECEIVING A MOTOR ERROR ALARM ON THE INSULIN PUMP DURING BASAL RATE INSULIN DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT KNOWN. DURING TROUBLESHOOTING, IT WAS STATED THE INSULIN PUMP HAD NOT BEEN EXPOSED TO A STRONG MAGNETIC FIELD. THE CUSTOMER WAS NOT USING THE SENSOR FEATURE. THE CUSTOMER WAS UNABLE TO COMPLETE THE REWIND SEQUENCE. IT WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. CUSTOMER WAS ALSO ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524994 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR