BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINMED QUICK SET

    MDR report key: 21261501 · Received January 29, 2025

    Report

    Report Number
    3003442380-2025-00104
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    January 1, 2025
    Report Date
    June 6, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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 6002120 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 IN THE TUBING AND/OR TUBING CONNECTORS (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). COMPLAINT INVESTIGATION. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. REFERENCE SAMPLES TEST RESULTS: ON THE VISUAL INSPECTION ACCORDING TO WI VERSION 3, WAS PERFORMED AND 10/10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST AIR FLOW ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10/10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: PACKAGING LOT: THE LOT 6002120 WAS PACKAGING ACCORDING TO THE WI VERSION 26, IN THE MACHINE MULTIVAC 08, ON 13/JUL/2023, WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT: THE LOT 3F05725 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, IN THE MACHINE MP08, ON 06/JUL/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F05727 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, IN THE MACHINE MP05, ON 10/JUL/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3G01534 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, IN THE MACHINE MP05, ON 12/JUL/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3G01535 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, IN THE MACHINE MP08, ON 13/JUL/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3G00674 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, IN THE MACHINE MP08, ON 10/JUL/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 05-JUN-2025 AGAINST MALFUNCTION CODE OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) AND LOT 6002120 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6002120 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 TUBING OR OCCLUSION ISSUES, HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO 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 OCCURRED IN TURKEY. IT WAS REPORTED THAT THE PATIENT FACED AN INSULIN FLOW BLOW ALARM EVENT ON 01-JAN-2025 DUE TO BLOCKAGE IN TUBING. 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
    1994944 MINMED QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A 6002120 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown