BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED QUICK-SET

    MDR report key: 22156254 · Received June 6, 2025

    Report

    Report Number
    3003442380-2025-10273
    Event Type
    Injury
    Date Received
    June 6, 2025
    Date of Event
    May 16, 2025
    Report Date
    June 25, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K160648
    Adverse Event
    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 STATES.

    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) WITH MALFUNCTION CODE OCCLUSION (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). IF THERE IS NO TROUBLESHOOTING, INCONCLUSIVE TROUBLESHOOTING, OR PARTIAL TROUBLESHOOT DONE AND IT CANNOT BE CONCLUDED TO BE INFUSION RELATED, REFER TO CANNOT BE DETERMINED IDD CANNOT BE DETERMINED. NO ESCALATION REQUIRED. THE BATCH 6010045 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 03 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 02 FOR THE OCCLUSION (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). IF THERE IS NO TROUBLESHOOTING, INCONCLUSIVE TROUBLESHOOTING, OR PARTIAL TROUBLESHOOT DONE AND IT CANNOT BE CONCLUDED TO BE INFUSION RELATED, REFER TO CANNOT BE DETERMINED CANNOT BE DETERMINED. NO ESCALATION REQUIRED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. FUNCTIONAL (FLOW TEST) TEST ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010045 WAS PACKAGED ACCORDING TO THE WI VERSION 82, PACKAGED IN THE MACHINE MULTIVAC 12, ON 03/NOV/2024 WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY DHR REVIEW: THE LOT 4K05698 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27, MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 02/NOV/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05699 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27, MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 03/NOV/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05701 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27, MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 02/NOV/2024 WITH A TOTAL OF (B)(4) UNITS. BUN DHR REVIEW: THE LOT 4K05092 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, MANUFACTURED IN THE MACHINE US05-US06, ON 28/OCT/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05093 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, MANUFACTURED IN THE MACHINE US05-US06, ON 02/NOV/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05094 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42, MANUFACTURED IN THE MACHINE US05-US06, ON 02/NOV/2024 WITH A TOTAL OF (B)(4) UNITS. GLUE TUBING DHR REVIEW: THE LOT 4K05679 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42, MANUFACTURED IN THE MACHINE GLUING 8, ON 29/OCT/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05680 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42, MANUFACTURED IN THE MACHINE GLUING 4-5-8, ON 30/OCT/2024 WITH A TOTAL OF(B)(4) UNITS. TRENDING: A QUERY WAS RUN IN DATABASE ON 25/JUN/2025 AGAINST MALFUNCTION CODE EVALUATED OCCLUSION (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). IF THERE IS NO TROUBLESHOOTING, INCONCLUSIVE TROUBLESHOOTING, OR PARTIAL TROUBLESHOOT DONE AND IT CANNOT BE CONCLUDED TO BE INFUSION RELATED, REFER TO CANNOT BE DETERMINED CANNOT BE DETERMINED. NO ESCALATION REQUIRED AND LOT 6010045 AND OTHER 1 COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER 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 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 STATES. IT WAS REPORTED THAT THE PATIENT WENT TO EMERGENCY ROOM AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA AND OCCLUSION EVENT. BLOOD GLUCOSE LEVEL WAS 388 MG/DL AT THE TIME OF THE EVENT. THE DURATION OF HOSPITALIZATION WAS LESS THAN 24 HOURS. PATIENT GOT TREATED WITH INTRAVENOUS (IV) INSULIN. PATIENT EXPERIENCED THE SYMPTOMS OF SICK/UNWELL. 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
    1391409 MINIMED QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A 6010045 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R