BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20542308 · Received October 28, 2024

    Report

    Report Number
    3003442380-2024-29749
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    August 1, 2024
    Report Date
    December 19, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    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).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4), MDR 3003442380-2024-29749. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER G4. ADDITIONAL INFORMATION: THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D9: DEVICE AVAILABLE FOR EVALUATION HAS BEEN SELECTED AS YES & DATE RETURNED TO MFG WAS ADDED AS WELL. H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY: THE COMPLAINT: (B)(4) HAS BEEN EVALUATED AS A SEVERITY 5 CASE. THE LOT: 6000576 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTIONS (WI) GUIDELINE FOR TEST OF REFERENCE. SAMPLES VERSION 11 FOR THE CODE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE. THE FOLLOWING TEST WAS PERFORMED: 2 USED SET WAS PROVIDED AND THERE IS A VISIBLE DEFECT ON THE RECEIVED SAMPLE, 2 CANNULA IS FOUND WITH KINKED CANNULA AT TIP. VISUAL TEST ACCORDING TO WITH WI VERSION 43, 2 RETURNED CANNULA NOT TEST PASSED. FUNCTIONAL TEST (FLOW). ACCORDING TO WITH 4802122 VERSION 9, 2 RETURNED CANNULAS PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT: 6000576 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 14 ON THE PACKING PROCESS IN THE LINE 7 ON 22/APR/2023 WITH (B)(4) PIECES. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. CONCLUSION SUMMARY OF THE RELATED EVENT. AS A RESULT OF THE FOLLOWING: ON THE INVESTIGATION ON RETURNED SAMPLES, TWO SOFT CANNULAS IS FOUND WITH KINKED AT TIP, FAILURE FOUND IS NOT RELATED TO MANUFACTURING PROCESS, THIS OCCURRED DURING USE, NO REPORTED HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO THIS FAILURE. NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKETING SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR) PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. ON (B)(6) 2024, REPORTED THAT PATIENT FACED 6 INFUSION SETS CANNULA KINKED AFTER 3 OR MORE HOURS OF INSERTION. INSERTION SITE WAS ABDOMEN. INFUSION SET HAD BEEN USED FOR 6-12 HOURS. THE BLOOD GLUCOSE LEVEL WAS HIGH. THEREFORE, PATIENT WAS TREATED WITH MULTIPLE DAILY INJECTION. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. COMPANY 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 AVAILABLE.

    Description of Event or Problem · 0

    TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337624 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6000576 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male