BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 20072780 · Received August 26, 2024

    Report

    Report Number
    3003442380-2024-22622
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 26, 2024
    Report Date
    November 14, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244019492
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR 1951722 - MDR 3003442380-2024-22622 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 INVESTIGATION ASSOCIATED WITH RELATED EVENT 1951722 HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKETING SURVELLIENCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE MARKET QUALITY REVIEW (OMQR) PROCEDURE. THE IDENTIFIED MALFUNCTION CODE, "TUBING IS DAMAGED (E.G. KINKED, DEFORMED, TWISTED, COLLAPSED OR PINCHED)", IS NOT ASSOCIATED WITH A DESIGN OR MANUFACTURING-RELATED COMPLAINT ISSUE. THEREFORE, A DETAILED INVESTIGATION OR INSPECTION OF REFERENCE SAMPLES IS NOT REQUIRED. BATCH REVIEW: LOT 6002303 WAS MANUFACTURED ON 18-AUG-2023, IN MACHINE 10, WITH A TOTAL OF 36,000. THE BATCH RECORD WAS REVIEWED TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED, AND NO ISSUES WERE FOUND. REVIEW OF THE BATCH RECORD SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WAS FOUND WITHIN THE DOCUMENTATION. CONCLUSION SUMMARY OF THE RELATED EVENT: DUE TO THE FOLLOWING BATCH RECORD REVIEW YIELDING NO DISCREPANCIES AND NO NON-CONFORMANCE (NC) WAS GENERATED DURING PRODUCTION. IN THE MANUFACTURING PROCESS THE TUBING IS INSPECTED AGAINST SPECIFICATIONS BEFORE RELEASED FOR PRODUCTION. HOWEVER, DURING USE COULD ALSO ACCIDENTALLY KINK THE TUBING BY WINDING IT OR GETTING THE TUBING CAUGHT ON OR IN SOMETHING. NO FURTHER ACTION IS REQUIRED FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - DEVICE 9 OF 10. E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES.

    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. IT WAS REPORTED THAT THE PATIENT FACED AN EVENT WHERE THE TUBING KINKED AT THE CONNECTOR BETWEEN THE TUBING AND RESERVOIR PROMPTING PATIENT TO CHANGE THE SET. PATIENT CONFIRMED TO BE DRIVING WHEN SHE DISCOVERED THERE WAS A PROBLEM. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969113 MINIMED QUICK-SET UNO COMFORT SHORT 46/13 SC1 MINI FPA UNOMEDICAL A/S MMT-368A 6002303 05705244019492

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown