BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19677396 · Received July 4, 2024

    Report

    Report Number
    3003442380-2024-12475
    Event Type
    Malfunction
    Date Received
    July 4, 2024
    Date of Event
    February 28, 2024
    Report Date
    December 2, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018181
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - 3003442380-2024-12475. 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 DEVICE HISTORY RECORD (DHR) REVIEW WAS DOCUMENTED WITHIN THE CHILD. COMPLAINT INVESTIGATION: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6002941, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002941 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 105 AND MANUFACTURED IN THE LINE 3 ON 08-JUN-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT A NON-CONFORMANCES NC WAS RAISED DUE TO LOCATION 10 IN CLEAN ROOM 3 FROM AIR VIABLE TEST IS OUT OF SPECIFICATION. THIS NC IS NOT RELATED TO CLAIMED MALFUNCTION. FURTHERMORE, THE OVERALL REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMS THAT ALL REQUIRED PROCESS-RELATED TESTS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: ONE NON-CONFORMANCE (NC) WAS RAISED DURING AND FOUND UNRELATED TO THE REPORTED MALFUNCTION 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.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - MDR DEVICE 6 OF 7.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT PATIENT FACED SEVEN INFUSION SET SITE LEAKING FROM SITE HOUSING EVENTS SINCE 28-FEB-2024. THE SET WAS IN USE FOR TWO HOURS. BLOOD GLUCOSE LEVELS WERE BETWEEN 300-499 MG/DL AT THE TIME OF EVENT. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526131 AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002819 6002941 05705244018181

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male