BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21487250 · Received February 28, 2025

    Report

    Report Number
    3003442380-2025-02518
    Event Type
    Injury
    Date Received
    February 28, 2025
    Date of Event
    January 26, 2025
    Report Date
    July 9, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (B)(6).

    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: THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE PRODUCT USED OFF-LABEL OR AGAINST THE CONTRAINDICATIONS OR NOT ACCORDING TO THE INSTRUCTION FOR USE (IFU). ONLY USE IF NO ACTUAL PRODUCT MALFUNCTION HAS BEEN REPORTED. THE BATCH 6001424 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATIONS. THE REFERENCE SAMPLES FOR BATCH 6001424 WERE PREVIOUSLY TESTED IN (B)(4) ON 12/FEB/2025. TEST RESULTS: VISUAL TEST ACCORDING TO WORK INSTRUCTION (WI) VERSION 1 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001424 WAS MANUFACTURED ACCORDING TO THE WI VERSION 75 PACKING IN THE MULTIVAC 12, ON 26/MAY/2024, 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 RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 09/JUL/2025 AGAINST MALFUNCTION CODE PRODUCT USED OFF-LABEL OR AGAINST THE CONTRAINDICATIONS OR NOT ACCORDING TO THE INSTRUCTION FOR USE (IFU). ONLY USE IF NO ACTUAL PRODUCT MALFUNCTION HAS BEEN REPORTED AND LOT 6001424 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, HARM REPORTABLE, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER 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 ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED FOR LESS THAN 24 HOURS ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL WAS ABOVE 400 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INSULIN PEN AND SALINE. INSERTION SITE WAS ABDOMEN. SYMPTOMS OCCURRED AT THE TIME OF EVENT IS NAUSEA. NO FURTHER INFORMATION WAS 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
    648234 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6001424

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention