BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 8003256 · Received October 24, 2018

    Report

    Report Number
    8031673-2018-00943
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Date of Event
    September 28, 2018
    Report Date
    December 13, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4), PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR SERIAL NUMBER (B)(4), WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. CORRECTED DATA: THE AIA-900, SERIAL NUMBER (B)(4), WAS INSTALLED ON 12-OCT-2017. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FROM INSTALLATION DATE THROUGH AWARE DATE . THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. THE SUBSTRATE SYRINGE WAS RETURNED TO TOSOH INSTRUMENT SERVICE CENTER FOR INVESTIGATION. FUNCTIONAL TESTING DID NOT REPRODUCE OR CONFIRM THE REPORTED SUBSTRATE SYRINGE FAILURE. DEVICE EVALUATION BY MANUFACTURER: THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS UNKNOWN.

    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 WAS AT CUSTOMER'S SITE TO RESOLVE REPORTED ISSUE. FSE CONFIRMED CUSTOMER HAD CORRECTLY REGISTERED THE VITAMIN D - PRETREATMENT AND VITAMIN D CONJUGATE WITHOUT ISSUES. FSE MONITORED THE INSTRUMENT WHILE RUNNING AND NOTICED INSTRUMENT WAS CORRECTLY SWITCHING BETWEEN THE PRETREATMENT BOTTLES AND CONJUGATE AS WELL. FSE FURTHER REVIEWED INSTRUMENT LOGS AND NOTICED INSTRUMENT SEEMS TO BE FAILING PRECISION. FSE ADJUSTED THE Z AXIS POSITION ON THE SMALL BOTTLE BOTTOM. FSE ALSO ADJUSTED THE HAND TOUCH AND LIQUID LEVEL SENSE. FSE ATTEMPTED PRECISION TEST, WHICH FAILED. FSE NOTICED BUBBLES IN THE SUBSTRATE SYRINGE WHICH WAS CREATING PRECISION ISSUES. FSE REPLACED SUBSTRATE SYRINGE. CUSTOMER SUCCESSFULLY COMPLETED DAILY CHECK AND QUALITY CONTROL RUN. THE FOLLOWING PRECISION TEST ON VITAMIN D CONTROLS COMPLETED SUCCESSFULLY WITHIN ACCEPTABLE RANGE. CUSTOMER RAN MORE THAN 30 PATIENT SAMPLES, AND SOME COMPLETED WITH LOW RESULTS, CUSTOMER RERAN THEM AND THEY ARE STILL LOW. FSE CONCLUDED THE INSTRUMENT RESULTS ARE CONSISTENT. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-900 INSTRUMENT IS FUNCTIONING AS EXPECTED. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4). THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 12: FLAGS AND ERROR MESSAGES, STATES THE FOLLOWING: IF THE CONCENTRATION COULD NOT BE CALCULATED BECAUSE THE CONCENTRATION OF THE SPECIMEN WAS LOW <L: THE MEASUREMENT RESULT IS LESS THAN THE LOWER LIMIT OF MEASUREMENT (LOWER LIMIT OF MEASUREMENT OF THE TEST FILE (ASSAY.L)), PREVENTING IT FROM BEING CALCULATED. PRINT AND DISPLAY (RATE VALUE): OUTPUTS THE MEASUREMENT VALUES. PRINT AND DISPLAY (CONCENTRATION VALUE): BECOMES BLANK. RS232C OUTPUT (CONCENTRATION VALUE): CONFORMS TO THE SETTING THAT IS APPLICABLE TO THE CASE WHERE NO CALCULATION RESULT IS SET IN THE HOST. RS232C OUTPUT (FLAG) : < THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS PENDING INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING VITAMIN D - PRETREATMENT REAGENT (PT) SHORTAGE NOT DETECTING SECOND BOTTLE ERROR ON THE AIA-900 INSTRUMENT. THE CUSTOMER ALSO STATED THE AIA-900 IS NOT RECOGNIZING THE PRETREATMENT 2 OR LEVEL SENSING WHEN THE PRETREATMENT 2 BOTTLE IS EMPTY AND ERROR PT EMPTY OCCURS. THE CUSTOMER ALSO REPORTED THAT TWO (2) PATIENT SAMPLE RESULTS OBTAINED LOW (<L FLAG) ON VITAMIN D AND WERE REPORTED OUT OF THE LAB; HOWEVER, NO MEDICAL ACTION TOOK PLACE BECAUSE THE CUSTOMER RECOGNIZED THE LOW RESULTS. BOTH PATIENT SAMPLES WERE REPEATED AND OBTAINED ACCEPTABLE RESULTS. . TECHNICAL SUPPORT SPECIALIST (TSS) REVIEWED REAGENT REGISTRATION SCANNING WITH THE HAND HELP BARCODE FOR PRETREATMENT 1 BOTTLE AND THE AIA-900 AUTOMATICALLY ADDS PRETREATMENT 2 , THE CUSTOMER ADDS A SECOND SET IN THE REAGENT REGISTRATION THE SAME WAY BUT ERRORS OCCURS WHEN THE AIA-900 DOES NOT LEVEL SENSE THE EMPTY PT 2 BOTTLE AND MOVES TO THE NEXT. TSS RECOMMENDED MANUAL REGISTRATION BUT CUSTOMER REQUESTED ONSITE SERVICE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE TWO (2) LOW VITAMIN-D PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841694 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1