BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 8177356 · Received December 18, 2018

    Report

    Report Number
    8031673-2018-05342
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    November 27, 2018
    Report Date
    December 18, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    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: A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE CONFIRMED THE ERROR BY RUNNING A SORTER MACRO AND OBSERVING HESITATION IN ONE TRAY IN THE Z-AXIS. FSE PERFORMED SORTER CUP PICKUP ALIGNMENTS AND THEN RAN THE SORTER CUP PICKUP MACRO MULTIPLE TIMES WITHOUT ANY ERRORS. FSE THEN RAN THE DAILY CHECK AND PATIENT SAMPLES WITHOUT ANY ERRORS. THE INSTRUMENT WAS OPERATING CORRECTLY. THERE WERE NO FURTHER ACTIONS REQUIRED BY FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6) FROM 27-OCT-2017 THROUGH AWARE DATE OF (B)(4) 2018. THERE WERE NO SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 12 - FLAGS AND ERROR MESSAGES STATES THE FOLLOWING: [2204] SORTER NOT PICKED UP CUP. CAUSE: THE CUP HOLD SENSOR S027 FAILED TO DETECT A CUP DURING A CUP PICKUP OPERATION. A RETRY WILL TAKE PLACE, AND IF THERE IS NO IMPROVEMENT A MF FLAG WILL BE ATTACHED TO THE MEASUREMENT RESULT. ACTION: CHECK THE UPPER SURFACE OF THE TEST CUP FOR CONTAMINATION, CHECK THE SEAL FOR CURLING, AND SO ON. IF THE TROUBLE OCCURS FREQUENTLY, CONTACT THE TOSOH LOCAL REPRESENTATIVES. CHECK S027, THE CUP PICKUP POSITION, AND THE CUP PICKUP OPERATION, AND ALSO CHECK THE CUP CONTROL SENSORS S023 TO S026, AND THE SORTER SCANNING OPERATION. THE MOST PROBABLE CAUSE OF ERRORS 2204 WAS THE SORTER WAS OUT OF ALIGNMENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED A 2204 SORTER NOT PICKED UP CUP ERROR MESSAGE WITH THE AIA-900 INSTRUMENT. THE CUSTOMER STATED THAT IT OCCURRED INTERMITTENTLY WHILE RUNNING QUALITY CONTROLS (QC). THE CUSTOMER TRIED MOVING THE CUPS TO ANOTHER POSITION IN THE SORTER BUT IT DID NOT HAVE AN EFFECT ON THE ERROR. THE INSTRUMENT WAS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF PARATHYROID HORMONE (IPTH) PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016562 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1