BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 19846806 · Received July 27, 2024

    Report

    Report Number
    3003442380-2024-16402
    Event Type
    Malfunction
    Date Received
    July 27, 2024
    Date of Event
    June 26, 2024
    Report Date
    December 18, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    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 1923768 - MDR 3003442380-2024-16402 - DEVICE 3 OF 5.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4)- MDR 3003442380-2024-16402. 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. THE LOT 6005339 IN QUESTION WAS MANUFACTURED AT THE (B)(4) SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDELINE FOR TEST OF REFERENCE. SAMPLES VERSION 11 FOR THE CODE LEAKAGE (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). 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 42 TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. VISUAL TEST ACCORDING TO WITH WI VERSION 18 TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WI VERSION 102 TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 ACCORDING TO WI VERSION 7 TEST REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6005339 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 68 ON THE PACKING PROCESS IN THE LINE INSET 6, 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. OTHER ONE COMPLAINTS RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, 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. COMPLAINT INVESTIGATIONS: 5 UNUSED SETS WERE RECEIVED TO TEST THE PRODUCT. THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WITH WI VERSION 42 TEST ON 5 UNUSED SETS, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. VISUAL TEST ACCORDING TO WITH WI VERSION 18 TEST ON 5 UNUSED SETS, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WITH WI VERSION 102 TEST ON 5 UNUSED SETS, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 ACCORDING TO WITH WI VERSION 7 TEST ON 5 UNUSED SETS, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. CONCLUSION SUMMARY OF THE RELATED EVENT: NO DEFECTS ON SAMPLES RETURNED. 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

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRIA. IT WAS REPORTED THAT THE PATIENT FACED EVENTS OF LEAKAGE WITH FIVE INFUSION SETS. PATIENT SAW AND SMELLED INSULIN BOTH IN THE SILICONE SLEEVE AND IN THE AMPOULE COMPARTMENT. PATIENT TTOK CORRECTION BOLUSES WITH PEN. PATIENT WAS GUIDED TO DRY THE AMPOULE COMPARTMENT WELL, TAKE A NEW RESERVOIR FROM A NEW PACK AND INSET FROM A NEW PACK. DURING THE PRIMING, INSULIN ALSO DRIPPED OUT OF THE TUBE CAP. 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
    1457869 INSET UNO INSET II 80/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL A/S 86-080-52B6 6005339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female