BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINMED QUICK SET

    MDR report key: 20742337 · Received November 21, 2024

    Report

    Report Number
    3003442380-2024-32488
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    October 12, 2024
    Report Date
    August 19, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017931
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    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. THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6000507 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE CODE OCCLUSION (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). NO T/S, INCONCLUSIVE T/S, OR PARTIAL T/S DONE, REFER TO CANNOT BE DETERMINED. CANNOT BE DETERMINED. NO ESCALATION REQUIRED. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. FUNCTIONAL (FLOW) TEST ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6000507 WAS MANUFACTURED ACCORDING TO THE WI VERSION 75, PACKAGED IN THE MACHINE MULTIVAC 12, ON 02/APR/2023, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY DHR REVIEW: THE LOT 3C05606 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26, MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 30/MAR/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3D00816 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26, MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 10/APR/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING TUBING DHR REVIEW: THE LOT 3C04337 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, MANUFACTURED IN THE MACHINE 05, ON 24/MAR/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3C05562 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, MANUFACTURED IN THE MACHINE 05, ON 30/MAR/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3C05551 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, MANUFACTURED IN THE MACHINE 04, ON 30/MAR/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 WERE IDENTIFIED; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 18/AUG/2025 AGAINST MALFUNCTION CODE OCCLUSION (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). NO T/S, INCONCLUSIVE T/S, OR PARTIAL T/S DONE, REFER TO CANNOT BE DETERMINED. CANNOT BE DETERMINED. NO ESCALATION REQUIRED AND LOT 6000507 AND OTHER 1 COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES RELATED TO THE COMPLAINT, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, OTHER 1 COMPLAINT RECEIVED ON 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.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6), PATIENT COUNTRY: DUBAI.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED ARAB EMIRATES. IT WAS REPORTED THAT, THE PATIENT WAS HOSPITALIZED DUE TO INFUSION SET BLOCK ALARM EVENT THAT TOOK PLACE ON (B)(6) 2024. PATIENT'S BLOOD GLUCOSE LEVEL AT THE TIME OF ISSUE WAS 400 MG/DL. PATIENT'S KETONE LEVELS WERE MEASURED AT 2 MMOL/L. PATIENT WAS TREATED VIA INTRAVENOUS INSULIN. PATIENT WAS HOSPITALIZED FOR 1 DAY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427041 MINMED QUICK SET UNO QUICK-SET 110/6 SC1 MECA FPA UNOMEDICAL A/S MMT-398A 6000507 05705244017931

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization