BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 19584402 · Received June 21, 2024

    Report

    Report Number
    3003442380-2024-09609
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    March 11, 2024
    Report Date
    November 6, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244021099
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 1 OF 2.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4)- MDR 3003442380-2024-09609. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED BRAND NAME UNDER D1, COMMON DEVICE NAME UNDER D2, SERIAL NUMBER, MODEL NUMBER,PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER 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 PER 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 DEVICE HISTORY RECORD (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 6003534, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003534 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 108 AND MANUFACTURED IN THE LINE INSET 7 ON 03/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT THE LOT 3J03684 WAS MANUFACTURED ACCORDING TO THE WI VERSION 108 AND MANUFACTURED IN THE LINE INSET 7 ON 30/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED THAT DURING OUTGOING TEST 6, ONE EXTENDED SAMPLING WAS RAISED: ONE FOR TUBE ATTACHED TO THE TAPE. ONE EXTENDED SAMPLING WAS ACCEPTED. THEREFORE, THE DEVICE HISTORY RECORD (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 EXTENDED WAS RAISED DURING THE PROCESS UNRELATED TO THE MALFUNCTION REPORTED, THEREFORE, NO NON-CONFORMANCE (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. IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SETS LEAK EVENTS ON 11-MAR-2024. THE INFUSION SET WAS IN USE FOR A DAY FOR ALL EVENT. THE PATIENT REPORTED THAT INFUSION SET TUBING WAS PULLED OUT. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. 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
    283381 INSET UNO INSET I 80/6 GREY TCAP 10PACK US FPA UNOMEDICAL A/S 1003912 6003534 05705244021099

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male