BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8031673-2018-00080

    MDR report key: 7277766 · Received February 16, 2018

    Report

    Report Number
    8031673-2018-00080
    Event Type
    Malfunction
    Date Received
    February 16, 2018
    Date of Event
    January 19, 2018
    Report Date
    February 16, 2018
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: ON 22-JAN-2018, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. FSE FOUND THE CUP TRANSFER Z-AXIS PULSE MOTOR TO BE DEFECTIVE. FSE REPLACED THE Z-AXIS PULSE MOTOR AND RAN CUP TRANSFER TEST THREE (3) TIMES WITHOUT ANY ISSUES. FSE ALSO RAN QUALITY CONTROLS (QC) AND ALL RESULTS ARE IN ACCEPTABLE RANGE AND NO ERRORS APPEARED. THE AIA-900 INSTRUMENT WAS FUNCTIONING AS INTENDED AND THE ERRORS CLEARED. NO FURTHER ACTION REQUIRED FROM FIELD SERVICE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WERE PERFORMED FOR SERIAL NUMBER (B)(4) FROM 19-DEC-2016 THROUGH 19-JAN-2018. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-900 OPERATOR'S MANUAL, UNDER SECTION 12: FLAGS AND ERROR MESSAGES INDICATE THAT 4151 C.TRANS-Z HOME DETECT ERROR IS GENERATED WHEN THE HOME SENSOR S062 FAILED TO BE ACTIVATED AFTER THE TRANSFER Y MOVED TOWARD THE HOME POSITION. A RETRY WILL TAKE PLACE, AND IF THERE IS NO IMPROVEMENT A MF (MECHANICAL FAILURE) FLAG WILL BE ATTACHED TO THE MEASUREMENT RESULT. THE SOLUTION IS FOR THE CUSTOMER TO CONTACT TOSOH LOCAL REPRESENTATIVES AND CHECK S062 AND PM061 FOR A POSSIBLE MALFUNCTION. MESSAGE 5100 ASSAY OPERATION ABORTED IS GENERATED WHEN THE MEASUREMENT WAS INTERRUPTED DUE TO THE OCCURRENCE OF A PHENOMENON THAT PREVENTED THE CONTINUATION OF MEASUREMENT. THE SOLUTION IS FOR THE CUSTOMER TO CHECK THE ABORT CAUSE OR SOURCE OF. THE MOST PROBABLE CAUSE OF THE ISSUE IS DUE TO DEFECTIVE CUP TRANSFER Z-AXIS PULSE MOTOR.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED GETTING MESSAGES 4151 C.TRANS-Z HOME DETECT ERROR AND 5100 ASSAY OPERATION ABORTED ERROR ON THE AIA-900 INSTRUMENT. THE CUSTOMER IS UNABLE TO RUN PATIENT SAMPLES FOR HEMOGLOBIN A1C (HBA1C). FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF HBA1C PATIENT RESULTS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Patients

    Seq Age Sex Outcome Treatment
    1