BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED QUICK-SET

    MDR report key: 19737773 · Received July 14, 2024

    Report

    Report Number
    3003442380-2024-14311
    Event Type
    Injury
    Date Received
    July 14, 2024
    Date of Event
    June 4, 2024
    Report Date
    December 12, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-14311. 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. COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 12-DEC-2025 AGAINST "LOT NUMBER 6002740 AND SIMILAR MALFUNCTION CODE(S): SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - REDUCED FLOW, SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE, THE REVIEW CONFIRMED THAT LOT 6001316 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 12-DEC-2025 AGAINST "LOT NUMBER" CRITERIA EQUAL 6001316 AND SIMILAR MALFUNCTION CODES SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - REDUCED FLOW, SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001316 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION [75] AND MANUFACTURED IN THE MACHINE M12 ON 16/MAY/2023 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, OF THE LOT 3E03320 WAS MANUFACTURED ACCORDING TO THE WI VERSION [26] AND MANUFACTURED IN THE QUICKSET LINE, ON 17/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, OF THE LOT 3E01053 WAS MANUFACTURED ACCORDING TO THE WI VERSION [26] AND MANUFACTURED IN THE [QUICKSET LINE], ON 16/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, OF THE LOT 3E01052 WAS MANUFACTURED ACCORDING TO THE WI VERSION [26] AND MANUFACTURED IN THE [QUICKSET LINE], ON 15/MAY/2023, WITH A TOTAL OF (B)(4) UNITS THE SUB-ASSEMBLY GLUING OF TUBING, OF THE LOT 3E01024 WAS MANUFACTURED ACCORDING TO THE WI VERSION [38] AND MANUFACTURED IN THE GLUING MACHINE 08, ON15/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF TUBING, OF THE LOT 3E00988 WAS MANUFACTURED ACCORDING TO THE WI VERSION [38] AND MANUFACTURED IN THE GLUING MACHINE 08, ON 13/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF TUBING, OF THE LOT 3E01023 WAS MANUFACTURED ACCORDING TO THE WI VERSION [38] AND MANUFACTURED IN THE [GLUING MACHINE 08], ON 12/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF TUBING, OF THE LOT 3E01029 WAS MANUFACTURED ACCORDING TO THE WI VERSION [38] AND MANUFACTURED IN THE [GLUING MACHINE 08], ON 13/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED IN ACCORDANCE WITH APPLICABLE PROCEDURES, AND ONE NON-CONFORMANCE (NC) WAS RAISED DURING STERIGENICS PROCESS (THE ACCUSOLO SOFTWARE WAS UPGRADED AT STERIGENICS G.P.). AND IS NOT ASSOCIATED TO THE REPORTED ISSUE ON THIS COMPLAINT. THEREFORE, THE OVERALL REVIEW OF THE DHR CONFIRMS THAT ALL REQUIRED PROCESS-RELATED TESTS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED IN RELATION TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS; NO ISSUES NOTED. VISUAL EVIDENCE REVIEW: NO PHOTO WAS PROVIDED TO SUPPORT VISUAL CONFIRMATION OF THE REPORTED ISSUE. CONCLUSION: UNABLE TO PERFORM VISUAL VERIFICATION; ASSESSMENT BASED ON AVAILABLE DOCUMENTATION ONLY. CAPA DETERMINATION ASSESSMENT - CONCLUSION SUMMARY OF COMPLAINT. INVESTIGATION: BASED ON THE INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI (MONTHLY TRIPS AND ALERTS).

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 4 INFUSION SET CANNULA BENT EVENTS ON (B)(6) 2024. THE BLOOD GLUOSE LEVEL WAS 400 MG/DL ON 04-JUN-2024. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2024 BECAUSE BLOOD GLUCOSE WAS 800 MG/DL. UNOMEDICAL DO NOT SEE BENT 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 WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510063 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6001316 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H