BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3222979 · Received July 12, 2013

    Report

    Report Number
    2032227-2013-02890
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A PROTRUDED/LOOSE DRIVE SUPPORT DISK.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE RECEIVED THE LETTER REGARDING THE DRIVE SUPPORT CAP, AND STATED THAT HIS INSULIN PUMP MIGHT BE AFFECTED. HAD THE CUSTOMER INSPECT THE CAP, AND HE STATED IT WAS INDENTED BUT IT ALSO APPEARS TO BE LOOSE. ADVISED THE CUSTOMER THAT IT'S SUPPOSED TO BE INDENTED BUT DEFINITELY NOT LOOSE. 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
    323461 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR