BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21135090 · Received January 13, 2025

    Report

    Report Number
    3003442380-2024-36887
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 17, 2024
    Report Date
    November 6, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244018051
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED ARAB EMIRATES.

    Additional Manufacturer Narrative · 0

    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 6001588, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001588 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 AND PACKAGED IN THE MACHINE MULTIVAC 08 ON 30-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, ASSEMBLY OF QUICK SET OF THE LOT 3E04530 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 26 AND MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 30-MAY-2023, WITH A TOTAL OF 29,200 UNITS. THE SUB-ASSEMBLY, TUBE GLUING SET OF THE LOT 3E04450 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 38 AND MANUFACTURED IN THE MACHINE 04, ON 29-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, TUBE GLUING SET OF THE LOT 3E04501 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 38 AND MANUFACTURED IN THE MACHINE 04, ON 30-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, TUBE GLUING SET OF THE LOT 3E04500 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 38 AND MANUFACTURED IN THE MACHINE 08, ON 29-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, TUBE GLUING SET OF THE LOT 3E04496 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 38 AND MANUFACTURED IN THE MACHINE 05, ON 30-MAY-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.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED ARAB EMIRATES IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2024. THE LEAKAGE WAS IN THE TUBING. THE INFUSION SET WAS IN USE FOR THE SAME DAY. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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
    512048 MINIMED QUICK-SET UNO QUICK-SET 110/9 SC1 MECA FPA UNOMEDICAL UM-D MMT-396A 6001588 05705244018051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown