BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7368156 · Received March 23, 2018

    Report

    Report Number
    8031673-2018-00223
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    February 23, 2018
    Report Date
    June 27, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.10. 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. H.3. DEVICE EVALUATION BY MANUFACTURER: INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    H.10. 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. ON (B)(6)2018, THE TSS FOLLOWED UP WITH CUSTOMER AND LEFT A VOICEMAIL ASKING ABOUT THE BHCG ISSUE; NO RESPONSE WAS RECEIVED FROM CUSTOMER. ON (B)(6)2018 THE CUSTOMER INFORMED TSS, THEY WILL RUN THE PRECISION AND CALL BACK. ON (B)(6)2018 TSS CALLED CUSTOMER TO FOLLOW UP AND LEFT A VOICEMAIL FOR CUSTOMER. NO RESPONSE OR FOLLOW UP RECEIVED FROM CUSTOMER. ON (B)(6)2018 TSS FOLLOWED UP AGAIN BY EMAIL ASKING FOR THE PRECISION OF 1:10 DILUTION OR DATA TO CONFIRM HER OBSERVATION, NO RESPONSE FROM CUSTOMER. ON(B)(6)2018 CUSTOMER SAID SHE WOULD DO THE PRECISION REQUESTED. THE CUSTOMER COMPLETED THE PRECISION AND SUBMITTED A PRECISION ON BHCG. COEFFICIENT OF VARIATION (CV) WAS 3.0%. RESULT DOES NOT CONFIRM ISSUES WITH PRECISION. MOST PROBABLE CAUSE IS UNKNOWN. UNABLE TO CONFIRM THE REPORTED ISSUE. AIA 360 ASSAY SPECIFICATIONS FOR ST BHCG BHCG ASSAY PROCEDURE 1. ENSURE A SUFFICIENT QUANTITY OF STAIA-PACK BHCG TESTCUPS FOR THE NUMBER OF SAMPLES TO BE RUN. 2. LOAD PATIENT SAMPLES AS INSTRUCTED IN THE OPERATOR'S MANUAL AND PROCEED WITH ANALYSIS. PROCEDURAL NOTES 1) LYOPHILIZED SUBSTRATE MUST BE COMPLETELY DISSOLVED. 2) LIGAND ASSAYS PERFORMED BY THE TOSOH AIA SYSTEMS REQUIRE THAT THE LABORATORY USE WATER DESIGNATED BY THE COLLEGE OF AMERICAN PATHOLOGISTS AS CLASS I OR BY NCCLS (CLSI) AS TYPE I. WATER SHOULD BE TESTED ATLEAST ONCE PER MONTH AND SHOULD BE FREE OF PARTICULATE MATTER INCLUDING BACTERIA. THE PH OF THE WATER SHOULD ALSO BE ROUTINELY TESTED. FOR FURTHER INFORMATION, CONSULT "PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY; APPROVED GUIDELINE -THIRD EDITION", OCTOBER 1997 NCCLS DOCUMENT C3-A3. 3) IF A SERUM OR PLASMA SPECIMEN TOTAL BETA HCG CONCENTRATION IS FOUND TO BE GREATER THAN THE LINEARITY LIMIT OF THE ASSAY,400 MIU/ML, THE SPECIMEN SHOULD BE DILUTED WITH THE BHCG SAMPLE DILUTING SOLUTION AND REASSAYED ACCORDING TO THE ASSAY PROCEDURE. THERE COMMENDED DILUTION FOR SAMPLES CONTAINING GREATER THAN 400 MIU/ML IS 1:10 OR1:100. ITIS DESIRABLE TO DILUTE THE SERUM OR PLASMA SAMPLE SO THAT THE DILUTED SAMPLE READSBETWEEN5 AND400 MIU/ML. THE DILUTION FACTOR SHOULD BE ENTERED INTO THE SOFTWARE. FOR FURTHER INFORMATION ON THE DILUTION OF SPECIMENS, REFER TO THE AIA SYSTEM OPERATOR'S MANUAL. 4) THE AIA SYSTEM SCAN STORE TWO DIFFERENT CALIBRATION CURVES FOR EACH ANALYTE AT ONE TIME. THEREFORE, UP TO TWO DIFFERENT LOTS OF ST AIA-PACK BHCG TESTCUP SCAN BE USED DURING THE SAME RUN. 5) IF THE ASSAY SPECIFICATIONS FOR THIS TEST ARE NOT ALREADY IN THE SYSTEM SOFTWARE, THE SPECIFICATIONS MUST BE ENTERED UNDER TEST CODE 071. PRECISION TOTAL PRECISE WAS DETERMINED BY THE DUPLICATE ASSAY OF THREE CONTROLS IN 20 SEPARATE RUNS. THE MEANS OF EACH RUN WERE USED TO CALCULATE THE STANDARD DEVIATION (SD) AND COEFFICIENT OF VARIATION (CV). H.11. CORRECTED DATA: PLEASE REFER TO SECTIONS BRAND NAME, COMMON DEVICE NAME, SERIAL # AND DEVICE EVALUATED BY MFR.

    Description of Event or Problem · 0

    ON (B)(6) 2018, CUSTOMER REPORTED IMPRECISION WITH 1:10 DILUTIONS OF BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) ON THE AIA 360 INSTRUMENT. THE CUSTOMER STATED THAT PRECISION IS POOR IF SHE RUNS A 1:10 ON ONE SAMPLE WITH 3 TEST CUPS (TC). TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO DO A PRECISION ON BHCG STRAIGHT, TO RULE OUT ANY INSTRUMENT MALFUNCTION AND TO SEND PRINTOUTS OF EXAMPLES OF THE DILUTION; CUSTOMER DID NOT SEND THE PRECISION STUDIES. TECHNICAL SUPPORT SPECIALIST (TSS) HAS MADE MULTIPLE UNSUCCESSFUL FOLLOW UP ATTEMPTS TO THE CUSTOMER.

    Description of Event or Problem · 0

    ON (B)(6)2018, CUSTOMER REPORTED IMPRECISION WITH 1:10 DILUTIONS OF BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) ON THE AIA 360 INSTRUMENT. THE CUSTOMER STATED THAT PRECISION IS POOR IF SHE RUNS A 1:10 ON ONE SAMPLE WITH 3 TEST CUPS (TC). TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO DO A PRECISION ON BHCG STRAIGHT, TO RULE OUT ANY INSTRUMENT MALFUNCTION AND TO SEND PRINTOUTS OF EXAMPLES OF THE DILUTION; CUSTOMER DID NOT SEND THE PRECISION STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207759 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1