BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 20923614 · Received December 13, 2024

    Report

    Report Number
    3003442380-2024-15725
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    November 16, 2024
    Report Date
    November 5, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (3003442380-2024-15725), WAS SUBMITTED ON 13-DEC-2024. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 28-OCT-2023. 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. PER REVISION 21 OF PROCEDURE (B)(4), A CHILD INVESTIGATION IS NOT REQUIRED TO DOCUMENT THE DEVICE HISTORY RECORD (DHR) REVIEW FOR A TYPE 2 REPORTABLE COMPLAINT. HOWEVER, THE CHILD WAS CREATED TO ALLOW THE PARENT RECORD TO ADVANCE TO REVIEW AND SUMMARY. SINCE IT WAS CREATED, THE DEVICE HISTORY RECORD (DHR) REVIEW WAS DOCUMENTED WITHIN THE CHILD. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6003966, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003966 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 AND PACKAGED IN THE MACHINE MULTIVAC 12 ON 28-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, ASSEMBLY OF QUICK SET OF THE LOT 3K03769 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 26 AND MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 29-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, ASSEMBLY OF QUICK SET OF THE LOT 3K03766 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 25 AND MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 28-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, ASSEMBLY OF QUICK SET OF THE LOT 3K03767 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 25 AND MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 29-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, TUBE GLUING SET OF THE LOT 3K02798 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 40 AND MANUFACTURED IN THE MACHINE 04-05-08, ON 27-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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE; NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: ARGENTINA.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ARGENTINA. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2024. THE BLOCKAGE WAS IN THE TUBING. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601235 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6003966 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown