BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARISOFT

    MDR report key: 19663569 · Received July 3, 2024

    Report

    Report Number
    8021545-2024-01653
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    March 28, 2024
    Report Date
    November 9, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018723
    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) - MDR DEVICE 1 OF 4.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4) - MDR 8021545-2024-01653. 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 1901917 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, ADHESIVE PATCH LIFTS OR DETACHES DURING USE, 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: 6003760 WAS MANUFACTURED ON 20-OCT-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 (B)(6). IT WAS REPORTED THAT THE PATIENT FACED ISSUE WITH 4 INFUSION SET'S ADHESIVE ON 28-MAR-2024. THE INFUSION SET FELL OFF DURING USE. THE PATIENT CONFIRMED THE INFUSION SET FELL OFF WHILE DOING PHYSICAL ACTIVITY/SWEATING, SWIMMING, OR BATHING. THE SET WAS IN USE FOR NOT MORE THAN 36 HOURS AND PATIENT RESOLVED THE EVENT BY REPLACING 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
    684455 VARISOFT UNO COMFORT SHORT 80/13 TCAP 10PK INT FPA UNOMEDICAL A/S 1002828 6003760 05705244018723

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female