BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4223095 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-47410
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 17, 2011
    Report Date
    October 17, 2011
    Manufacturer
    MEDTRONIC MINIMED
    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

    CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION. A21 AFTER BATTERY CHANGE DUE TO BROKEN SOLDER JOINT C13 ON I/B. NO UNEXPECTED BATTERY OUT LIMIT ALARM NOTED. 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

    CUSTOMER REPORTED THAT THE INSULIN PUMP RETURNED MULTIPLE ERROR ALARMS DURING BASAL. CUSTOMER ALSO REPORTED RECEIVING A BATTERY OUT LIMIT EACH TIME SHE CHANGED THE INSULIN PUMP'S BATTERY. BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706224 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1