BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 19982048 · Received August 14, 2024

    Report

    Report Number
    3003442380-2024-20845
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    July 14, 2024
    Report Date
    September 2, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K160648
    Product Problem
    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 ACCORDING TO MALFUNCTION. THE LOT 6002387 IN QUESTION WAS PRODUCED AT REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WORK INSTRUCTIONS (WI) VERSION 11. COMPLAINT INVESTIGATIONS. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR CLICK AND STATIC PULL TEST BASE-CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE FOLLOWING TEST WAS PERFORMED: VISUAL INSPECTION: (VERSION.8) CONNECTOR QUALITY CRITERIA FOR PRINTING. FUNCTIONAL 1.- (VERSION.9) QUALITY ALERT CLICK TEST. FUNCTIONAL 2.- (VERSION.45) INSTRUCTIONS FOR STATIC PULL TEST. SEE ATTACHMENT (B)(4) COMPLAINT TEST REPORT.PDF FOR THE DETAILS. BATCH REVIEW THE BATCH LISTED IN THE DATABASE COMPLAINT PARENT RECORD WAS REVIEWED AND CONFIRMED TO BE ACCURATE. UNO QUICK-SET 60/9 SC1 MECA WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) CODE 1728394 AND MANUFACTURING LOT NUMBER 6002387 ON (B)(6)2023 AND (B)(4) FINAL UNITS IN THE MACHINES (B)(4) WERE MANUFACTURED. THE BATCH RECORD CONFIRMS THIS INFORMATION. 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). PATIENT COUNTRY:(B)(6).

    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, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED INFUSION SET TUBING CAME APART. THE SITE FOR INSERTION WAS RIGHT ABDOMEN . THE INFUSION SET WAS IN USE FOR 1 DAY. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264029 MINIMED QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL A/S MMT-431AG 6002387 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown