BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5997646 · Received October 4, 2016

    Report

    Report Number
    2032227-2016-26113
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    November 19, 2013
    Report Date
    November 19, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS NOTED THAT THE PUMP PASSED BASIC OCCLUSION, PRIME/COMPROMISED FORCE SENSOR SYSTEM AND DISPLACEMENT TESTS. THE PUMP WAS STUCK IN A MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING THE TESTING. THEY WERE UNABLE TO CONFIRM THE MOTOR POSITION ENCODER ERROR ALARM DUE TO OVERWRITTEN HISTORY FILE. THE PUMP HAD CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS. NOTE: THIS IS A REMEDIATION MDR. MEDTRONIC DIABETES IMPLEMENTED REVISED MDR REPORTABILITY CRITERIA EFFECTIVE ON (B)(6) 2014. SUBSEQUENTLY, MEDTRONIC DIABETES CONDUCTED A ONE YEAR RETROSPECTIVE REVIEW OF COMPLAINTS. THIS EVENT WAS RETROSPECTIVELY IDENTIFIED TO BE REPORTABLE BASED ON THE REVISED MDR REPORTABILITY CRITERIA. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND MOTOR POSITION ENCODER ERROR ALARM. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS UNKNOWN. TROUBLESHOOTING WAS NOT ABLE TO RESOLVE THE ISSUE. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649827 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWL

    Patients

    Seq Age Sex Outcome Treatment
    1