BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3092064 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-93107
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 7, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARM MOTOR ERROR DURING THE BASIC OCCLUSION TEST, DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNIT WAS RECEIVED WITH MISSING END CAP STICKER. MOTOR PASSED MOTOR TEST.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE HAD HIGH BLOOD GLUCOSE; STATED THAT HER INSULIN PUMP DRIVE SUPPORT CAP IS STICKING OUT AND UNIT ALARMED WHILE TRYING TO PRIME. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193959 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR