BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3121995 · Received May 21, 2013

    Report

    Report Number
    2032227-2013-01896
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BROKEN DRIVE SUPPORT DISK END CAP. PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND ALARMED DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP DRIVE SUPPORT CAP IS STICKING OUT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224211 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR