BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 6519698 · Received April 25, 2017

    Report

    Report Number
    3004209178-2017-47473
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Date of Event
    July 11, 2013
    Report Date
    July 11, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARMED DURING REWIND DUE TO CORRODED ON MOTOR HOME SWITCH. ALSO. CORROSION FOUND ON LCD BOARD. HD (B)(6) 2013. 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. THIS IS A REMEDIATION MDR. MEDTRONIC DIABETES IMPLEMENTED REVISED MDR REPORTABILITY CRITERIA EFFECTIVE ON JULY 1, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS UNKNOWN. TROUBLESHOOTING WAS NOT PERFORMED. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301193 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWL

    Patients

    Seq Age Sex Outcome Treatment
    1