BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 22290979 · Received June 19, 2025

    Report

    Report Number
    3003442380-2025-10802
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    May 30, 2025
    Report Date
    September 11, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017573
    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: ARGENTINA.

    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: REVISION 21 OF (B)(4) DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6003957, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003957 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 AND PACKAGING IN THE MACHINE MULTIVAC 12 ON 24-OCT-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, ASSEMBLY OF QUICK SET OF THE LOT 3K03745 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 23-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, ASSEMBLY OF QUICK SET OF THE LOT 3K01278 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 15-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, ASSEMBLY OF QUICK SET OF THE LOT 3K03743 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 23-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, ASSEMBLY OF QUICK SET OF THE LOT 3L01384 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 10-NOV-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, ASSEMBLY OF QUICK SET OF THE LOT 3K03746 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 24-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: AS A RESULT OF THE FOLLOWING: 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 ARGENTINA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA WAS BROKEN (B)(6) 2025 THE EVENT OCCURRED WITHIN THREE HOURS OF INSERTION. THE INSERTION SITE WAS ABDOMEN. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN 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
    1684142 MINIMED QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A 6003957 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown