BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARISOFT

    MDR report key: 19583761 · Received June 21, 2024

    Report

    Report Number
    8021545-2024-01313
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    May 1, 2024
    Report Date
    October 30, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018785
    PMA / PMN Number
    K162812
    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 3.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4)- MDR 8021545-2024-01313. 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 6003427 WAS MANUFACTURED ON 30/SEP/2023, IN MACHINE 10, WITH A TOTAL OF (B)(4). 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. NO FURTHER ACTION IS REQUIRED FOR THIS COMPLAINT. THE ACRYLIC GLUE ON THE ADHESIVE IS NOT APPLIED BY CONVATEC AND THE ADHESIVE MATERIAL HAS BEEN MANUFACTURED AND INSPECTED IN ACCORDANCE WITH ALL SPECIFICATIONS, BATCH DOCUMENTATION AND THE REQUIREMENTS ACCORDING TO 21 CFR PART 820: QUALITY SYSTEM REGULATION AND ISO EN 13485:2016: MEDICAL DEVICES-QUALITY MANAGEMENT SYSTEMS.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA CRIMPED EVENTS ON 01-MAY-2024, 04-MAY-2024 AND 18-MAY-2024. THE EVENT OCCURED WITHIN 3 HOURS OF INSERTION. THE SITE OF INSERTION WAS AT ABDOMEN. THE BLOOD GLUCOSE LEVEL WAS 100-200 MG/DL. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES 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
    1182861 VARISOFT UNO COMFORT 60/17 TCAP 10PK INT FPA UNOMEDICAL A/S 1002830 6003427 05705244018785

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male