BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARISOFT

    MDR report key: 19571352 · Received June 19, 2024

    Report

    Report Number
    8021545-2024-01235
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    May 10, 2024
    Report Date
    November 13, 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

    SUPPLEMENTAL REPORT 01 - MDR (B)(4)- MDR 8021545-2024-01235. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4. 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 (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 ON MARKET QUALITY REVIEW (OMQR). THE IDENTIFIED MALFUNCTION TUBING IS DAMAGED (E.G. KINKED, DEFORMED, TWISTED, COLLAPSED OR PINCHED), 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 6003229 WAS MANUFACTURED ON 07-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. IN THE MANUFACTURING PROCESS THE TUBING IS INSPECTED AGAINST SPECIFICATIONS BEFORE RELEASED FOR PRODUCTION. HOWEVER, DURING USE COULD ALSO ACCIDENTALLY KINK THE TUBING BY WINDING IT OR GETTING THE TUBING CAUGHT ON OR IN SOMETHING. NO FURTHER ACTION IS REQUIRED FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1890627 - MDR 8021545-2024-01235 - DEVICE 1 OF 3.

    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 THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 3 INFUSION SET KINK IN TUBBING EVENTS ON 10-MAY-2024. INFUSION SET HAS BEEN USED FOR LESS THAN 24 HOURS. THE BLOOD GLUCOSE LEVEL WAS 280-300MG/DL. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577363 VARISOFT UNO COMFORT SHORT 80/13 TCAP 10PK INT FPA UNOMEDICAL A/S 1002828 6003229 05705244018723

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female