BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 1418502 · Received July 17, 2009

    Report

    Report Number
    MW5012015
    Event Type
    Malfunction
    Date Received
    July 17, 2009
    Date of Event
    July 9, 2009
    Report Date
    July 17, 2009
    Manufacturer
    MEDTRONIC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC QUICK-SET PARADIGM MMT-396 LOT 8200968 MALFUNCTIONED BY NOT INFUSING INSULIN CAUSING A VERY HIGH GLUCOSE READING. FREQUENCY: CONTINUOUS INFUSION. ROUTE: SQ. DATES OF USE: 2009. DIAGNOSIS: IDDM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC QUICK-SET PARADIGM INFUSION SET, 23 IN 9 MM FPA MEDTRONIC MMT-397 8200968

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR