BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 19444127 · Received June 1, 2024

    Report

    Report Number
    3003442380-2024-05380
    Event Type
    Malfunction
    Date Received
    June 1, 2024
    Date of Event
    March 31, 2024
    Report Date
    November 14, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1878403 - MDR 3003442380-2024-05380 - DEVICE 1 OF 3.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-05380. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER, 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. REVISION 21 OF PROCEDURE (B)(4), A CHILD INVESTIGATION IS NOT REQUIRED TO DOCUMENT THE DEVICE HISTORY RECORD (DHR) REVIEW FOR A TYPE 2 REPORTABLE COMPLAINT. HOWEVER, THE CHILD WAS CREATED TO ALLOW THE PARENT RECORD TO ADVANCE TO REVIEW AND SUMMARY. SINCE IT WAS CREATED, THE DHR REVIEW WAS DOCUMENTED WITHIN THE CHILD. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6002869, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DHR REVIEW: THE LOT 6002869 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 106 AND MANUFACTURED IN THE LINE 5 ON 01/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE REVIEW OF THE DHR REVEALED THAT, ONE NON-CONFORMANCE (NC) WAS FOUND WITH NUMBER 1741191, DISCREPANCY BETWEEN THE IFU (INS-910-2) IMPLEMENTED VS THE INITIAL SCOPE AND IMPACT ASSESSMENT OF THE CCR FOR AUTOSOFT XC AND WOMBAT. THEREFORE, THE DHR CONFIRMS THAT ALL REQUIRED TESTS RELATED TO THE PROCESS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: ONE NC RAISED DURING STERILIZATION PROCESS UNRELATED TO COMPLAINT CODE, THEREFORE, NO NC RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, 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

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT FACED THREE INSERTION WITHOUT REMOVING NEEDLE GUARD EVENTS . THE EVENTS OCCURED WITHIN 3 HOURS OF INSERTION.THE INSERTION SITE WAS AT THE ABDOMEN. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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
    327889 INSET UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 6002869

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male