BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3090731 · Received May 2, 2013

    Report

    Report Number
    3004209178-2013-93081
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARM DURING THE BASIC OCCLUSION TEST DUE TO LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP RECEIVED WITH MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE INSULIN ALARMED MOTOR ERROR. EXPLAINED MOTOR ERROR ALARM AND CORRECTED. CUSTOMER STATES THAT THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. CUSTOMER STATED THAT SHE CANNOT REWIND THE INSULIN PUMP. ADVISED CUSTOMER TO RETURN THE INSULIN PUMP FOR ANALYSIS. DISCONTINUE USE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191801 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR