BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5326615 · Received December 24, 2015

    Report

    Report Number
    2032227-2015-78322
    Event Type
    Malfunction
    Date Received
    December 24, 2015
    Date of Event
    October 13, 2015
    Report Date
    December 10, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARM DURING OCCLUSION TEST AND UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR RESISTOR. MOTOR PASSED MOTOR TEST. HOWEVER, THE INSULIN PUMP PASSED IDLE CURRENT TEST, RUN CURRENT TEST, SELF-TEST, OFF NO POWER TEST, UNEXPECTED RESTART ERROR TEST, BASIC OCCLUSION TEST, DISPLACEMENT TEST. THE INSULIN PUMP WAS RECEIVED WITH MISSING SEGMENTS DUE TO CRACKED LCD ZEBRA CONNECTOR. THE INSULIN PUMP WAS HAD MINOR SCRATCHED DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE INSULIN PUMP WAS RETURNED FOR FAILURE ANALYSIS. THE REASON FOR THE RETURN WAS UNKNOWN. THE CUSTOMER'S BLOOD GLUCOSE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851770 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1