BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5981691 · Received September 27, 2016

    Report

    Report Number
    2032227-2016-24312
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 6, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FAILED DISPLACEMENT TEST FOLLOWED BY A MOTOR ERROR ALARM DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. THE PUMP WAS UNABLE TO PERFORM FUNCTIONAL TEST INCLUDING SELF-TEST, UNEXPECTED ERROR TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST, DISPLACEMENT TEST OR VERIFY ALARM DUE TO MOTOR ERROR ALARMS. THE PUMP WAS RECEIVED WITH MISSING END CAP STICKER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL OF SPI TO MOTOR PIC COMMUNICATION ERROR, EXCESSIVE NO DELIVERIES AND MRI EXPOSURE FROM THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 86 MG/DL. THE CUSTOMER STATED THAT SHE WENT IN FOR AN MRI AND WORE IT IN THE MACHINE. THE CUSTOMER STATED THAT THE PUMP GAVE REPEATED ALARMS. THE CUSTOMER WILL RETURN THE PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631881 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR