BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3982006 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-90002
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. THERE WAS ALSO A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE AND CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS NOTED DURING A VISUAL INSPECTION.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 THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER STATED THAT NO BUTTONS HAD BEEN PRESSED FOR MORE THAN 3 MINUTES. ADVISED THE CUSTOMER TO SEEK MEDICAL ASSISTANCE BECAUSE THERE WAS NO BACK UP PLAN. THE BLOOD GLUCOSE READING WAS NOT AVAILABLE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457857 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWP

    Patients

    Seq Age Sex Outcome Treatment
    1