BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19294675 · Received May 11, 2024

    Report

    Report Number
    3003442380-2024-00809
    Event Type
    Malfunction
    Date Received
    May 11, 2024
    Report Date
    October 20, 2025
    Product Code
    FPA
    UDI-DI
    05705244014541
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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: REVISION 21 OF 3709030 DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6000257, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6000257 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 64 AND MANUFACTURED IN THE LINE INSET 9 ON 11/MAR/2023, WITH A TOTAL OF (B)(4) UNITS. THE REVIEW OF THE DHR REVEALED THAT DURING OUTGOING TEST 6, ONE EXTENDED SAMPLING WAS RAISED: ONE FOR CROOKED NEEDLE. ONE EXTENDED SAMPLING WAS ACCEPTED. 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 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.

    Additional Manufacturer Narrative · 0

    MDR 3003442380-2024-00806 - DEVICE 1 OF 4.

    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 AUSTRALIA ON 12-APR-2024, IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT EXPERIENCED INFUSION SET CANNULA WAS LEAKING AT THE SITE. WITHIN 3 OR MORE HOURS OF ABDOMEN INSERTION CUSTOMER NOTICED SYMPTOMS. AT THE TIME OF THE ISSUE, THERE WAS A TRACE OF KETONES AND HIGH BLOOD GLUCOSE (SPECIFIC VALUE UNKNOWN). THE INFUSION SET WAS USED FOR 1 DAY. ADDITIONALLY, PATIENT HAD CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION (MDI) TO ADDRESS HIGH BLOOD GLUCOSE AND INFUSION SET WAS REPLACED, INSULIN RESUMED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327456 AUTOSOFT 90 INSET II 2-PACK 60/6 GREY TCAP FPA 6000257 05705244014541

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown