BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINMED QUICK SET

    MDR report key: 19936705 · Received August 8, 2024

    Report

    Report Number
    3003442380-2024-19768
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 4, 2024
    Report Date
    September 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    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). 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 1933649 BEEN EVALUATED. THE BATCH 6002745 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION(WI) GUIDELINE FOR TEST OF REF. SAMPLES 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 VERSION 7 TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 ACCORDING TO VERSION 10 TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 3 ACCORDING TO VERSION 25 TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: - THE LOT 6002745 WAS MANUFACTURED ON THE PACKING PROCESS IN THE MULTIVAC 12, ON 18/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY REPORT (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.  NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SETS LEAKING AT SITE EVENTS ON (B)(6) 2024. THE INFUSION SET WAS IN USE FOR 1 DAY. BLOOD GLUCOSE LEVELS REPORTED DURING THE EVENT WAS 380 MG/DL. 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
    1530735 MINMED QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6002745 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown