BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINMED QUICK SET

    MDR report key: 22033847 · Received May 16, 2025

    Report

    Report Number
    3003442380-2025-09030
    Event Type
    Injury
    Date Received
    May 16, 2025
    Date of Event
    March 2, 2025
    Report Date
    September 30, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018051
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. 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 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 6003775, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003775 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 AND PACKAGING IN THE MULTIVAC M12 ON 25-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY OF THE LOT 3K04121 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND ASSEMBLED IN THE QUICKSET LINE, ON 25-OCT-2023, 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 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 TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION 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 A BENT CANNULA EVENT ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 26 MMOL/L AND THE PATIENT HAD WEAKNESS. THE PATIENT WENT TO EMERGENCY ROOM ON (B)(6) 2025 FOR FIVE HOURS. THE PATIENT WAS TREATED BY INTRAVENOUS INSULIN. COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. 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
    1880553 MINMED QUICK SET UNO QUICK-SET 110/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-396A 6003775 05705244018051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention