BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2883661 · Received December 21, 2012

    Report

    Report Number
    2032227-2012-08109
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH ALARMS DUE TO A LOOSE DRIVE SUPPORT DISK. UNABLE TO PERFORM THE BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS DUE TO THE ALARMS. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE INSULIN PUMP ALSO HAD A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED AND INSULIN SQUIRTED OUT DURING THE MANUAL PRIME. THE NUMBERS DID NOT APPEAR ON THE SCREEN, AND NO BEEPS WERE HEARD. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization