BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED QUICK-SET

    MDR report key: 22050472 · Received May 20, 2025

    Report

    Report Number
    3003442380-2025-09187
    Event Type
    Injury
    Date Received
    May 20, 2025
    Date of Event
    April 21, 2025
    Report Date
    July 15, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED ARAB EMIRATES.

    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) ACCORDING TO REFERENCE RESULTS COMPLAINT IS (B)(4) HAS BEEN EVALUATED. THE BATCH 6003136 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION OCCLUSION (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). THE BATCH 6003136 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE 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). 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, 05 SAMPLES OUT 05 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 05 SAMPLES OUT 05 SAMPLES PASSED THE TEST. NOTE: 5/10 REFERENCE SAMPLES WERE NOT ABLE TO BE TESTED FOR FLOW DUE TO THE SAMPLES WERE USED IN A SPECIAL INVESTIGATION UNDER CAPA 1999254. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003136 WAS MANUFACTURED ACCORDING TO THE WI VERSION (B)(4) MANUFACTURED IN THE MACHINE MULTIVAC 12, ON 12/SEP/2023 WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 3J00292 WAS MANUFACTURED ACCORDING TO THE WI 5 VERSION (B)(4) MANUFACTURED IN THE LINE ASSEMBLY QUICKSET, ON 11/SEP/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3J00293 WAS MANUFACTURED ACCORDING TO THE WI VERSION (B)(4) MANUFACTURED IN THE LINE ASSEMBLY QUICKSET, ON 12/SEP/2023 WITH A TOTAL OF (B)(4) UNITS. GLUE TUBING DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 3J00250 WAS MANUFACTURED ACCORDING TO THE WI VERSION (B)(4) MANUFACTURED IN THE MACHINE MP08,MP04 AND MP05, ON 09/SEP/2023 WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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 (B)(6) 2025 AGAINST MALFUNCTION OCCLUSION (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED) AND LOT 6003136 AND TWO MORE COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6003136 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: ON THE INVESTIGATION ON REFERENCE SAMPLES, NO ISSUE WERE FOUND RELATED TO LEAK, HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ONE MORE COMPLAINT WAS RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION, NO FURTHER ACTION ARE REQUIRED, THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED ARAB EMIRATES. A PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO AN INFUSION SET BLOCK ALARM INCIDENT. THE HOSPITALIZATION LASTED FOR 2 DAYS. AT THE TIME OF ADMISSION, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. TO MANAGE THE ELEVATED BLOOD GLUCOSE, INSULIN PENS WERE USED AS TREATMENT. VOMITING WAS IDENTIFIED AS ONE OF THE EVENTS THAT LED TO THE HOSPITAL ADMISSION. KETONE TESTING WAS PERFORMED, AND THE RESULTS CAME BACK POSITIVE. 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
    2129811 MINIMED QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A 6003136 05705244017573

    Patients

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