BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 6014902 · Received October 10, 2016

    Report

    Report Number
    2032227-2016-26896
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    August 6, 2013
    Report Date
    August 6, 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

    THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE BASIC OCCLUSION TEST AND WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO FAULTY DAMAGE FORCE SENSOR RESISTOR. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED THE MOTOR TEST. NO DAMAGE FOUND ON MOTOR. 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. NOTE: 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD A PRIME/FILL ANOMALY. THE BLOOD GLUCOSE VALUE WAS 163 MG/DL. THE CUSTOMER WAS IN THE HOSPITAL AND HAD DISCONNECTED THE INSULIN PUMP. DURING TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE, THE CUSTOMER INSERTED A BATTERY INTO THE INSULIN PUMP, DID THE REWIND BUT WAS UNABLE TO PRIME. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666696 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWS

    Patients

    Seq Age Sex Outcome Treatment
    1