BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19901703 · Received August 3, 2024

    Report

    Report Number
    3003442380-2024-18794
    Event Type
    Malfunction
    Date Received
    August 3, 2024
    Date of Event
    May 14, 2024
    Report Date
    October 16, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 (B)(4). CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2A, MODEL NUMBER, SERIAL NUMBER, AND PRIMARY UDI NUMBER 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 COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6005570 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITHWORK INSTRUCTIONS (WI) GUIDELINE FOR TEST OF REFERENCE. SAMPLES VERSION 11 FOR THE CODE OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAS BEEN REQUESTED. THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WITH WI VERSION 18, VERSION 39 TEST ON RETURNED UNUSED/USED/REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WITH WI VERSION10 TEST ON RETURNED UNUSED/USED/REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6005570 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 111 ON THE PACKING PROCESS IN THE LINE 1, ON 20/FEB/2024, WITH A TOTAL OF (B)(4) UNITS. 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: NO REPORTED HARM, NO DEFECT ON TEST, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1931506 - MDR 3003442380-2024-18794 - DEVICE 2 OF 8

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT PATIENT FACED EIGHT INFUSION SET BLOCKED ALARM (B)(6)2024. THE BLOCKAGE IS LOCATED IN THE TUBING. THE GLUCOSE LEVEL WAS HIGH (SPECIFIC VALUE UNKNOWN) AND THE PATIENT WAS TREATED WITH CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION ( MDI). NO FURTHER INFORMATION AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399886 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6005570 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female