BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP -

    MDR report key: 4241856 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50053
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION TEST, PRIME TEST, AND DISPLACEMENT TEST. HOWEVER, THE DEVICE WAS RECEIVED STUCK ON A MOTOR ERROR ALARM THAT OCCURRED DURING THE BOLUS OR BASAL DELIVERY. NO MOTOR POSITION ENCODER ERROR COULD BE CONFIRMED DUE TO AN ERASED HISTORY FILE. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE RESERVOIR TUBE WINDOW CORNERS, A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, AND MISSING THE END CAP STICKER.

    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. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE RECEIVED A MOTOR ERROR ALARM DURING PRIMING. CUSTOMER'S BLOOD GLUCOSE WAS 136 MG/DL. DURING TROUBLESHOOTING, IT WAS FOUND THAT CUSTOMER DOES NOT RECALL IF EXPOSED TO MAGNETIC FIELD OR MRI. CUSTOMER DOES NOT USE SENSOR FEATURES. CUSTOMER IS ABLE TO COMPLETE REWIND SEQUENCE. AFTER TROUBLESHOOTING, 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
    723562 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP - INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR