BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISETRONIC TENDER

    MDR report key: 309499 · Received December 19, 2000

    Report

    Report Number
    8021545-2000-00054
    Event Type
    Malfunction
    Date Received
    December 19, 2000
    Date of Event
    November 13, 2000
    Report Date
    December 19, 2000
    Manufacturer
    MAERSK MEDICAL A/S
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MAERSK MEDICAL WAS INFORMED BY DISETRONIC MEDICAL SYSTEMS, INC THAT A DIABETIC UNDER CONTINUOUS INSULIN PUMP THERAPY STATED THAT THE TUBING SEPARATED FROM THE LUER LOCK CONNECTION, THAT ATTACHES THE TUBING TO THE INFUSION PUMP. ONE USED SAMPLE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISETRONIC TENDER SUBCUTANEOUS INFUSION SET FPA MAERSK MEDICAL A/S PT 17/80 (5+5) 518338

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other 1. INSULIN,| 2. INSULIN INFUSION PUMP.