BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2833247 · Received November 15, 2012

    Report

    Report Number
    2032227-2012-07727
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    September 13, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST AND ALARMED DURING BASIC OCCLUSION TEST DUE TO LOOSE DRIVE SUPPORT DISK. UNIT HAD CRACKED RESERVOIR TUBE AND BATTERY TUBE THREADS, NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP WAS NOT READING THE CORRECT AMOUNT OF INSULIN UNITS LEFT AND THE INSULIN SQUIRTING DURING REWIND. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC MINIMED MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR