BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1A-600II

    MDR report key: 7528446 · Received May 19, 2018

    Report

    Report Number
    8031673-2018-00461
    Event Type
    Malfunction
    Date Received
    May 19, 2018
    Date of Event
    May 3, 2018
    Report Date
    May 19, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. FIELD SERVICE ENGINEERING (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING TROUBLESHOOTING, FSE FOUND THE SUBSTRATE NOZZLE IN THE WRONG LOCATION AND THE PROBE ASSAY TIP WAS CRUNCHED PREVENTING A TIP FROM ATTACHING TO IT. FSE REPLACED EACH WASH PROBE AND ALSO CLEANED AND CORRECTLY PLACED THE SUBSTRATE NOZZLE. TO VERIFY THE INSTRUMENT, FSE THEN RAN THE DAILY CHECK WITHOUT ANY ISSUE. THEY ALSO RAN 5 SAMPLES OF TOTAL T3 (TT3) WITH ACCEPTABLE RESULTS. THE INSTRUMENT WAS VERIFIED AS OPERATIONAL. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED ON (B)(4) 2018 FOR A1A-600 INSTRUMENT WITH SERIAL NUMBER (B)(4). THE SEARCH WAS CONDUCTED FROM (B)(4) 2017 THROUGH AWARE DATE (B)(4)2018 AND DID NOT FIND ANY SIMILAR COMPLAINTS DURING THE SEARCHED PERIOD. THE AIA-600 OPERATOR'S MANUAL UNDER CHAPTER 8- TROUBLESHOOTING STATES THAT A DL FLAG IS CAUSED BY THE FOLLOWING: OUT OF SUBSTRATE II, OR RUNNING WITH CLEANING SOLUTION. LOW DETECTOR LAMP INTENSITY. TO RESOLVE THE ISSUE, IT INDICATES THAT THE FOLLOWING MUST BE DONE: REPLENISH SUBSTRATE II, PERFORM SUBSTRATE BACKGROUND CHECK. CALL TOSOH BIOSCIENCE. THE MOST PROBABLE CAUSE OF THE DETECTOR LOW (DL) FLAG WAS A DAMAGED WASH PROBE TIP AND THE SAMPLE NOZZLE INCORRECTLY PLACED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED DETECTOR LOW (DL) FLAGS WITH THE A1A-600 INSTRUMENT. TECHNICAL SUPPORT ADVISED THE CUSTOMER TO MAKE UP NEW SUBSTRATE BUT THEY CONTINUED TO HAVE THE DL FLAGS. THE ANALYZER WAS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) AND 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
    370849 A1A-600II A1A-600II KHO TOSOH CORPORATION A1A-600II

    Patients

    Seq Age Sex Outcome Treatment
    1