BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19999021 · Received August 18, 2024

    Report

    Report Number
    3003442380-2024-21132
    Event Type
    Malfunction
    Date Received
    August 18, 2024
    Date of Event
    July 15, 2024
    Report Date
    October 30, 2024
    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

    INITIAL AND FINAL MDR (B)(4) - DEVICE 3 OF 5.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-21132. 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 DATABASE (B)(4) 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 SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE MARKET QUALITY REVIEW (OMQR) PROCEDURE. THE IDENTIFIED FOR MALFUNCTION CODE, SOFT CANNULA FOUND CRIMPED UPON REMOVAL FROM INFUSION SITE, 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 6000308 WAS MANUFACTURED ON17-MAR-2023, IN LINE 1, WITH A TOTAL OF 29,400. 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. SOFT CANNULA CRIMPING COULD OCCUR DURING SEVERAL STEPS OF MANUFACTURING AND WHEN THE TIP OF THE SOFT CANNULA IS DAMAGED, NO SAMPLES WERE RETURNED FOR INSPECTION. HOWEVER, DURING USE, SOFT CANNULA CRIMPING CAN BE CAUSED BY USING INCORRECT INSERTION TECHNIQUES OR CHOOSING AN INAPPROPRIATE INSERTION SITE OR CANNULA LENGTH. NO FURTHER ACTION IS REQUIRED FOR THIS COMPLAINT, IF NEW INFORMATION BECOMES AVAILABLE OR USED/UNUSED SAMPLES ARE RECEIVED, APPROPRIATE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED FIVE INFUSION SETS CANNULA CRIMPED EVENTS WITHIN 3 HOURS OF INSERTION. THE BLOOD GLUCOSE WAS REPORTED 380 MG/DL. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION.

    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
    2349804 AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002819 6000308 05705244018181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown