BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIO¿ ADVANCE

    MDR report key: 19846804 · Received July 27, 2024

    Report

    Report Number
    8021545-2024-02526
    Event Type
    Malfunction
    Date Received
    July 27, 2024
    Date of Event
    June 26, 2024
    Report Date
    October 7, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K173879
    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). (B)(6).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4) - MDR 8021545-2024-02526. 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 6002179 IN QUESTION WAS MANUFACTURED AT THE OSTED SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION-3802038 GUIDELINE FOR TEST OF REF. SAMPLES BUID-UMD VERSION 11 FOR THE CODE LEAKAGE FROM INFUSION SITE (SPECIFIC CAUSE NOT IDENTIFIED) 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 3A02067 VERSION 15 TEST ON REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WITH 4802122 VER. 9 INSTRUCTIONS PARA LA REALIZACIÓN DE LA PRUEBA DE FLUJO EN AGUA / INSTRUCTIONS FOR PERFORMING THE FLOW TEST IN WATER TEST ON REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 ACCORDING TO WITH 4802112 VER 44 TEST REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6002179 WAS MANUFACTURED ACCORDING TO THE DOCUMENT 3A02067 VERSION 14 ON THE PACKING PROCESS IN THE MACHINE SL03, ON 01/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD 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. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED LEAKAGE EVENTS WITH THREE INFUSION SETS AS WHEN THEY REMOVED THE SET THE SITE WAS MOIST AFTER THE SET WAS USED FOR 2 DAYS. THE LOCATION OF THE LEAKAGE WAS REPORTED TO BE STOMACH. PATIENT ALSO REPORTED A BIT OF SMELL OF INSULIN. PATINET'S BLOOD GLUCOSE LEVEL INCRETAED TO A LEVEL OF 14 MMOL/L. 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
    1457867 MIO¿ ADVANCE UNO MIO ADV. GREY 110/9 SC1 10-PK CAN FPA UNOMEDICAL A/S MMT-244A600 6002179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown