BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINMED QUICK SET

    MDR report key: 19981974 · Received August 14, 2024

    Report

    Report Number
    3003442380-2024-20943
    Event Type
    Injury
    Date Received
    August 14, 2024
    Date of Event
    July 13, 2024
    Report Date
    May 28, 2026
    Manufacturer
    UNOMEDICAL A/S
    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

    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 COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6002729 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION GUIDELINE FOR TEST OF REF. SAMPLES BUID-UMD VERSION 11 FOR THE CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION. COMPLAINT INVESTIGATIONS: THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WITH WORK INSTRUCTIONS VERSION 15. TEST ON REFERENCE SAMPLES, (B)(4) PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WITH WORK INSTRUCTIONS VERSION 10 TEST ON REFERENCE SAMPLES, (B)(4) PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WITH WORK INSTRUCTIONS VERSION 25 TEST ON REFERENCE SAMPLES, (B)(4) PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WITH WORK INSTRUCTIONS VERSION 10 TEST ON REFERENCE SAMPLES, (B)(4) PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6002729 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 77 ON THE PACKING PROCESS IN THE MACHINE 12, ON (B)(6)2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO REPORTED HARM, NO DEFECT ON TEST, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION. NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (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 COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED FOR RECORD (B)(4) ON 28-JUL-2025. COMPLAINT INVESTIGATION: THE REFERENCE SAMPLES CANNOT BE TESTED BECAUSE THERE WAS NO SPECIFIC MALFUNCTION TO INVESTIGATE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002729 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 77 ON THE PACKING PROCESS IN THE MACHINE 12, ON 14-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. TRENDING: A QUERY WAS RUN IN DATABASE ON 28-JUL-2025 AGAINST HARM CODE DIABETIC COMA OR EMERGENCY ADVANCED LIFE SUPPORT TO PREVENT LIFE THREATENING DETERIORATION, MALFUNCTION CODE NO MALFUNCTION DESCRIBES AND LOT 6002729 AND NO MORE COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT, HARM CODE AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ONLY ONE COMPLAINT RECEIVED ON THE LOT IN QUESTION AND HARM CODE, THE TEST ON REFERENCE SAMPLES WERE NOT TESTED SINCE A NO MALFUNCTION RELATED TO THE INFUSION SET WAS REPORTED, THEREFORE 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.

    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 THE UNITED STATES. ON (B)(6) 2024, PATIENT ENCOUNTERED HIGH BLOOD GLUCOSE. THE PATIENT WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS FOR 3 DAYS. THE BLOOD GLUCOSE LEVEL WAS REPORTED 400+ MG/DL AND TREATED WITH IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION). MOREOVER, THE PATIENT HAD BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. 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
    233903 MINMED QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL A/S MMT-397A 6002729 05705244017573

    Patients

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