BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4233622 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48782
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    March 20, 2014
    Report Date
    October 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR RESISTER. UNABLE TO VERIFY NO DELIVERY ALARM DUE TO PRIME ANOMALY. THE DEVICE WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS.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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSULIN PUMP WAS GIVING AN UNUSUAL NO DELIVERY ERROR ALARM. CUSTOMER STATED THAT AFTER REWINDING THE CUSTOMER INSERTED THE RESERVOIR AND PRESSED ACT. THEN THE DEVICE STARTED COUNTING INSULIN UNITS AND THEN GAVE A NO DELIVERY ALARM. STATED THE DEVICE WAS NOT WORKING. CUSTOMER'S BLOOD GLUCOSE WAS NOT PROVIDED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715931 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWS

    Patients

    Seq Age Sex Outcome Treatment
    1