BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 19339379 · Received May 17, 2024

    Report

    Report Number
    3003442380-2024-02362
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Report Date
    October 8, 2024
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR 1863725 - MDR. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D9: DEVICE AVAILABLE FOR EVALUATION HAS BEEN SELECTED AS YES & DATE RETURNED TO MFG WAS ADDED AS WELL. H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    MDR 3003442380-2024-02362- DEVICE 1 OF 10.

    Description of Event or Problem · 0

    TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT PATIENT FACED TEN INFUSION SETS CANNULA BENT EVENTS THAT CAUSE INSULIN FLOW BLOCK ALARM ON (B)(6) 2024. THE ISSUE WAS OCCURRED ON DAY 1 AND INFUSION SET WAS IN USE FOE ONLY 3 TO 4 HOURS. THE INSERTION SITE WAS AT ABDOMEN. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921510 QUICK SET PARADIGM UNO QUICK-SET 60/6 SC1 MECA FPA 5407389 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown