BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5092681 · Received September 21, 2015

    Report

    Report Number
    2032227-2015-46697
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    May 1, 2015
    Report Date
    September 2, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST AND PRIME TEST. THE DEVICE WAS RECEIVED STUCK IN MOTOR ERROR LOOP DURING BOLUS/BASAL DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND IT PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING TESTING. THE EXCESSIVE NO DELIVERY TEST AND OCCLUSION TEST WEREN'T PERFORMED DUE TO MOTOR ERROR ALARMS. THE DEVICE HAD CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE LCD WINDOW, AND SCRATCHED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL, THE INSULIN PUMP ALARMED MOTOR ERROR AND NO DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS 380 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WAS NOT EXPOSED TO AN MRI OR STRONG MAGNETIC FIELD. THE DEVICE ALARMED DURING BOLUS. CUSTOMER DOESN'T USE THE SENSOR FEATURE AND WAS ABLE TO COMPLETE THE REWIND SEQUENCE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE, REVERT TO BACK UP PLAN, AND DEVICE NEED TO BE REPLACED. TROUBLESHOOTING FOR NO DELIVERY WASN'T PERFORMED AS IT WAS A PAST EVENT. CUSTOMER AGREED TO RETURN THE DEVICE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622796 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR