BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4233524 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48792
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    February 19, 2014
    Report Date
    February 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP PASSED DISPLACEMENT TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, EXCESSIVE NO DELIVERY TEST AND PRIME/A33 TEST. MOTOR PASSED MOTOR TEST. NO MOTOR ERROR ALARM. PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW. UNIT RECEIVED CRACKED CASE DISPLAY WINDOW CORNER. UNIT RECEIVED WITH CRACKED BATTERY TUBE THREADS. PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP. PUMP RECEIVED WITH CRACKED RESERVOIR TUBE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP RETURNED A MOTOR ERROR ALARM. BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712915 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1