BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21616867 · Received March 17, 2025

    Report

    Report Number
    3003442380-2025-03730
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    February 15, 2025
    Report Date
    May 12, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL (B)(4) - DEVICE 1 OF 2.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2025-03730. 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 REFERENCE SAMPLES FOR THE LOT 6001424 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 18/FEB/2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT COMPLAINT. (B)(4) COMPLAINT TEST. DEVICE HISTORY RECORD (DHR): THE LOT 6001424 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 75 PACKING IN THE MULTIVAC 12, ON 26/MAY/2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 06/MAY/2025 AGAINST HARM CODE PRIMARY PACK HAS INCOMPLETE OR OPEN SEAL/WELD, IS TORN, RIPPED, CONTAINS HOLES, EXHIBITS EXTERNAL CONTAMINATION (E.G., WATER MARKS, STAINS) OR PRODUCT IS TRAPPED IN PACKAGING (E.G., TRAPPED IN WELD) AND LOT 6001424 AND NO MORE COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6001424, HARM CODE AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ONLY ONE COMPLAINT RECEIVED ON THE LOT IN QUESTION AND HARM CODE, THE TEST ON REFERENCE SAMPLES WERE NOT TESTED SINCE A NO MALFUNCTION RELATED TO THE INFUSION SET WAS REPORTED, THEREFORE NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CAPA PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 02 - MDR (B)(4) - MDR 3003442380-2025-03730. MDR RETRACTION: AN INITIAL SUPPLEMENT MEDICAL DEVICE REPORT (MDR) WAS SUBMITTED ON MAY 29, 2025, WITH THE MANUFACTURING REPORT NUMBERS 3003442380-2025-03730 AND 3003442380-2025-03731 WITH COMPLAINT NUMBER (B)(4). THE CORRECT COMPLAINT NUMBER ASSOCIATED WITH THESE MFR NUMBERS IS (B)(4) AS ORIGINALLY REPORTED. THE REPORT NUMBERS THAT ARE BEING RETRACTED ARE AS FOLLOWS: SUPPLEMENTAL REPORT 01 - MDR (B)(4) - MDR 3003442380-2025-03730. SUPPLEMENTAL REPORT 01 - MDR (B)(4) - MDR 3003442380-2025-03731. 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 REFERENCE SAMPLES FOR THE LOT 6001424 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 18/FEB/2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT COMPLAINT. (B)(4) COMPLAINT TEST REPORT.PDF ATTACHED IN THIS RECORD. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001424 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 75 PACKING IN THE MULTIVAC 12, ON 26/MAY/2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 06/MAY/2025 AGAINST MALFUNCTION CODE PRIMARY PACK HAS INCOMPLETE OR OPEN SEAL/WELD, IS TORN, RIPPED, CONTAINS HOLES, EXHIBITS EXTERNAL CONTAMINATION (E.G., WATER MARKS, STAINS) OR PRODUCT IS TRAPPED IN PACKAGING (E.G., TRAPPED IN WELD) AND LOT 6001424 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: HARM NO REPORTABLE, NO DEFECT ON TESTS FOR RETURNED/RETENTION SAMPLES, NO NC RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET VIGILANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED ARAB EMIRATES. IT WAS REPORTED BY THE PATIENT THAT TWO SETS OF INFUSION SET FROM A BOX FOUND DAMAGED ON (B)(6) 2025. THE PATIENT CONFIRMED THAT THE PACKAGING WAS NOT SEALED PROPERLY. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

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

    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
    15265 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A 6001424

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown