BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3981711 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06195
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    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

    DEVICE RECEIVED WITH A MOTOR ERROR ALARM DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH .NO A33 ALARM. SCRATCHED LCD WINDOW, CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED DURING THE MANUAL PRIME. CUSTOMER'S CURRENT BLOOD GLUCOSE READING WAS REPORTED TO BE HIGH. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456756 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LWWB

    Patients

    Seq Age Sex Outcome Treatment
    1