BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 19349371 · Received May 20, 2024

    Report

    Report Number
    3003442380-2024-02555
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Report Date
    February 10, 2025
    Product Code
    FPA
    UDI-DI
    05705244017337
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 1 OF 9.

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER, EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY: THE COMPLAINT PR (B)(4) HAS BEEN EVALUATED. THE BATCH 6000471 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 1 FOR COMPLAINTS AREA FOR THE CODE "ADHESIVE PATCH LIFTS OR DETACHES DURING USE" PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WORK INSTRUCTION VERSION 1 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6000471 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION VERSION 75 MANUFACTURED IN THE MACHINE 12, ON 31/MAR/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. A QUERY WAS RUN IN DATABASE AGAINST MALFUNCTION CODE "ADHESIVE PATCH LIFTS OR DETACHES DURING USE" AND LOT 6000471 AND OTHER ZERO COMPLAINT HAS BEEN REGISTERED IN DATABASE SINCE THE LAST 12 MONTHS. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, OTHER ZERO COMPLAINTS RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKETING SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE MARKET QUALITY REVIEW (MQR) PROCEDURE."

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE FRANCE. ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT FACED AN ISSUE WITH INFUSION SET TAPE WAS NOT STICKING. THE PATIENT HAD REPORTED THAT PRODUCT NOT ADHERING ENOUGH LONG. THE PATIENT HAD TO CHANGE INFUSION SET EARLIER THAN THE SEVEN DAYS EXPECTED. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161412 QUICK SET PARADIGM UNO QUICK-SET 46/6 SC1 MECA FPA MMT-394A 6000471 05705244017337

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown