BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 19257357 · Received May 7, 2024

    Report

    Report Number
    3003442380-2024-00425
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Report Date
    March 13, 2025
    Product Code
    FPA
    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

    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

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE 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 (B)(4) HAS BEEN EVALUATED. THE BATCH 6003780 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 1 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 1 FOR THE CODE OCCLUSION (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). COMPLAINT INVESTIGATIONS. 1 USED SET WAS PROVIDED FOR INVESTIGATION. THE FOLLOWING TESTS WERE PERFORMED: VISUAL TEST ACCORDING TO WI VERSION 2, THE RETURNED SAMPLE TEST PASSED FUNCTIONAL TEST: UNDERWATER FLOW, ACCORDING TO WI VERSION 1, THE RETURNED SAMPLE, TEST PASSED. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: PACKAGING LOT: THE 6003780 WAS MANUFACTURED ACCORDING TO THE WI VERSION 70 MANUFACTURED IN THE MULTIVAC 12, ON 22/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. GLUE- TUBING LOT: THE 3K02786 WAS MANUFACTURED ACCORDING TO THE WI VERSION 70 MANUFACTURED IN THE MACHINE PEGADO 04, 05 AND 08, ON 19/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 06-MAR- 2025 AGAINST MALFUNCTION CODE OCCLUSION (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED) AND LOT 6003780 AND ONE OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE SINCE THE LAST 12 MONTHS. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO REPORTED HARM, NO DEFECT ON TEST, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION. NO FURTHER ACTIONS ARE REQUIRED.

    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 THE PATIENT FACED AN INSULIN FLOW BLOCKED ALARM. 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
    642777 QUICK SET PARADIGM UNO QUICK-SET 60/9 SC1 MECA FPA 6003780

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown