BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2810318 · Received October 31, 2012

    Report

    Report Number
    2032227-2012-07581
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 13, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K001829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP ALSO HAD A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULIN SQUIRTED OUT DURING THE MANUAL PRIME. THE NUMBERS DID NOT APPEAR ON THE SCREEN, AND NO BEEPS WERE HEARD. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP LZG FRN MEDTRONIC MINIMED MMT-511LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1