BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 17917848 · Received October 12, 2023

    Report

    Report Number
    3004529019-2023-00437
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    September 20, 2023
    Report Date
    October 12, 2023
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    KHO
    UDI-DI
    04560189284616
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER¿S SITE TO ADDRESS THE REPORTED EVENT. FSE CONFIRMED THE COMPLAINT BY EVALUATING THE SAMPLE NOZZLE. WHILE TROUBLESHOOTING, FSE FOUND THE SAMPLE NOZZLE CLOGGED AND THE LEVEL CIRCUIT NOT WORKING PROPERLY, AS WELL AS THE EKI BOARD SENSING WAS DEFECTIVE. FSE REPLACED THE SAMPLE NOZZLE AND THE EKI BOARD AND RESOLVED THE COMPLAINT. FSE REPAIRED AND VALIDATED THE ANALYZER BY SUCCESSFULLY PERFORMING QUALITY CONTROL RUN WITHOUT ERROR AND WITHIN ACCEPTABLE RANGE. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-2000 ANALYZER IS FUNCTIONING AS EXPECTED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(6). THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. AIA-2000 OPERATOR'S MANUAL ON THE APPENDIX 4: ERROR MESSAGES: (2070) CLOGGING DETECTED DURING SPECIMEN SUCTION BY MAIN ARM CAUSE: THE NEGATIVE PRESSURE DETECTED AFTER SPECIMEN SUCTION EXCEEDED THE STANDARD. THE SPECIFIED AMOUNT OF SPECIMEN MAY NOT HAVE BEEN OBTAINED BECAUSE THE SAMPLING NOZZLE WAS BLOCKED. THE MEASUREMENT RESULT WILL BE FLAGGED (SC FLAG). SOLUTION: VERIFY THAT THE SPECIMEN IS FREE OF SOLID SUBSTANCES (SUCH AS FIBRIN) OR THAT THERE IS SUFFICIENT VOLUME OF SPECIMEN IF IT IS PREPARED IN THE PRIMARY TUBE, AND RETRY THE MEASUREMENT. IF RETRY FAILS, CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILURES OF THE SAMPLE NOZZLE AND EKI BOARD.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED ERROR MESSAGE ¿2070 CLOGGING DETECTED DURING SPECIMEN SUCTION BY MAIN ARM¿ ON EVERY SAMPLE OF THE AIA-2000 ANALYZER. THE CUSTOMER POWERED ON AND OFF THE ANALYZER, PRIMED THE DILUENT, BUT THE ERROR PERSISTS. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT WHICH RESULTED IN A DELAYED REPORTING OF PATIENT SAMPLES FOR CREATINE KINASE MB ISOENZYME (CK-MB), CARDIAC TROPONIN I (CTNL 2), MYOGLOBIN (MYO), AND INTACT PARATHYROID HORMONE (IPTH). THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284522 AIA-2000 FLUOROMETER, FOR CLINICAL USE KHO TOSOH HI-TEC, INC. AIA-2000 ST N/A 04560189284616

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown