BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 22343135 · Received June 27, 2025

    Report

    Report Number
    3003442380-2025-11120
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    June 10, 2025
    Report Date
    September 3, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    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

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4. 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)(6) 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)(6). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(6) 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 75 AND PACKAGING IN THE MULTIVAC 08, ON 30/MAY/2023, WITH A TOTAL OF (B)(6) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 3E04450 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 38 AND MANUFACTURED IN THE MACHINE MP04, ON 29/MAY/2023, WITH A TOTAL OF (B)(6) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 3E04501 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 38 AND MANUFACTURED IN THE MACHINE MP04, ON 30/MAY/2023, WITH A TOTAL OF (B)(6) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 3E04500 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 38 AND MANUFACTURED IN THE MACHINE MP08, ON 29/MAY/2023, WITH A TOTAL OF (B)(6) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 3E04496 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 38 AND MANUFACTURED IN THE MACHINE MP05, ON 30/MAY/2023, WITH A TOTAL OF (B)(6) UNITS. 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 UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET TUBING DETACHED EVENT ON (B)(6) 2025 FROM TUBING CONNECTOR. INFUSION SET WAS USED FOR FEW HOURS. THE INSERTION SITE WAS THE ABDOMEN. BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF THE EVENT. THEREFORE, PATIENT TOOK PUMP CORRECTION FOR THE TREATMENT. 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
    972879 MINIMED QUICK-SET UNO QUICK-SET 110/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-396A 6001588 05705244018051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown