BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972053 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05066
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    April 27, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT PASSED THE REWIND, BASIC OCCLUSION, PRIME TEST AND DISPLACEMENT TESTS. HOWEVER, DEVICE RECEIVED STUCK IN THE MOTOR ERROR LOOP DURING BOLUS/BASAL DELIVERY. UNABLE TO CONFIRM ERROR ALARM DUE TO ERASED HISTORY FILE. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE FIXED PRIME. CUSTOMER STATED THAT THE INSULIN PUMP DID NOT DELIVER AN INSULIN BOLUS. CUSTOMER REPORTED HE DOES USE THE SENSOR FEATURE AND HE IS ABLE TO REWIND THE INSULIN PUMP. BLOOD GLUCOSE LEVEL 237 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447258 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR