BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240331 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49496
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND TEST, BASIC OCCLUSION TEST, PRIME TEST, AND MOTOR TEST. THE DEVICE WAS RECEIVED STUCK IN THE MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING TESTING. THE DEVICE HAD MINOR SCRATCHES ON LCD WINDOW AND SCRATCHES ON RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING PRIME. CUSTOMER'S BLOOD GLUCOSE READING WAS 96 MG/DL. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE OBSERVED. IT WAS REPORTED THAT CUSTOMER WAS UNABLE TO REWIND THE INSULIN PUMP. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722380 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR