BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSOH AIA-1800

    MDR report key: 6095388 · Received November 11, 2016

    Report

    Report Number
    3005529799-2016-00016
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    October 2, 2016
    Report Date
    April 17, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CONTACT OFFICE: (B)(4). MANUFACTURING SITE: TOSOH CORPORATION (MANUFACTURER) SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA MINATO-KU, TOKYO 1058623, JA. DATE REC¿D BY MFR: 13-OCT-2016; PMA/510K: 510K: K971103; FOLLOW UP #1; TYPE OF REPORTABLE EVENT: MALFUNCTION; IF FOLLOW-UP, WHAT TYPE: CORRECTION; DEVICE EVALUATED BY MFR: YES; DEVICE MANUFACTURE DATE: 11/01/2003; LABELED FOR SINGLE USE: NO; PATIENT CODE: 2692; NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT; DEVICE CODES: 2456; INCORRECT OR INADEQUATE TEST RESULTS; METHOD:CODE:3263; ACTUAL DEVICE NOT EVALUATED; RESULTS CODE:3221; NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED; CONCLUSION CODE: 67; UNABLE TO CONFIRM COMPLAINT. USAGE OF DEVICE: REUSE. ON 17-OCT-2016, FSE CONDUCTED FOLLOW-UP WITH THE CUSTOMER OVER THE PHONE TO ADDRESS THE REPORTED EVENT. FSE PERFORMED PRECISION TESTING FOR BOTH HGH AND LH II. HGH PRECISION RESULTS RETURNED WITHIN RANGE; HOWEVER, LH II PRECISION RESULTS RETURNED LOW. ON 18-OCT-2018 FSE COMPARED QUALITY CONTROL DATA FROM THE CUSTOMER FOR LH II FOR BIORAD LOTS 40301 & 40303. IT WAS SUBSEQUENTLY DETERMINED THAT BOTH RESULTS WERE CLOSE TO THE PI TARGET VALUES. ON 21-OCT-2016 FSE FOLLOWED UP AGAIN WITH THE CUSTOMER REGARDING THE REPORTED EVENT; HOWEVER, THE CUSTOMER REFUSED SERVICE AND STATED THEY WOULD CALL BACK IF NEEDED. NO FURTHER ACTION REQUIRED FROM FIELD SERVICE. ON 10/17/2016: HGH. PRECISION N = 15 AIA HGH TEST CUP LOT F916662; BIORAD QC1 LOT 40301 = 2.4% CV; OBSERVED MEAN = 3.33 NG/ML; TARGET MEAN = 3.2 NG/ML. ON 10/17/2016: LH II. PRECISION N = 15 LH II AIA TEST CUP LOT G713933; BIORAD QC1 LOT 40301 = NO CV INDICATED; OBSERVED MEAN = 1.297 MIU/ML; TARGET MEAN = 1.21 MIU/ML. ON 10/18/2016, LH II QC DATA RECEIVED. QC DATA WITHIN TARGET RANGE. QC BIORAD LOT 40301 = 1.21 MIU/ML; QC BIORAD LOT 40303 = 67.88 MIU/ML. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN AS THE CUSTOMER REFUSED SERVICE. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-(B)(4). SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2016, THE CUSTOMER REPORTED DISCREPANT PATIENT RESULTS FOR HGH AND LH II, WITH THEIR AIA-1800 STD ANALYZER. THE DISCREPANT RESULTS WERE DRAWN ON B)(6) 2016, RESPECTIVELY, USING GOLD TOP SST TUBES. ON 13-OCT-2016, FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR HGH AND LH II. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Description of Event or Problem · 1

    (B)(6) 2016: HGH SPECIMEN DRAWN INTO A GOLD TOP SST, POURED OFF INTO A BARCODED ALIQUOT TUBE, AND TESTED FOR HGH ON THE TOSOH AIA-1800 USING TOSOH TEST CUP LOT F916662 (EXPIRED). THE REPEAT TESTING WAS DONE ON THE ORIGINAL BARCODED ALIQUOT TUBE THAT HAD BEEN REFRIGERATED. ORIGINAL RESULT = 1.0 NG/ML, REPEAT RESULT = 8.2 NG/ML. (B)(6) 2016, 4:00 PM: ONE LH II SPECIMEN DRAWN INTO A GOLD TOP SST, POURED OFF INTO A BARCODED ALIQUOT TUBE. (B)(6) 2016, 8:17 AM: ALIQUOT FROM GOLD TOP SST TESTED FOR LH II ON THE TOSOH AIA-1800 USING TEST CUP LOT G713933. ORIGINAL RESULT = 3.28 MIU/ML, REPEAT RESULTS (3 TIMES) ALL RESULTS <0.2 MIU/ML. ON 10/13/2016 TOSOH BIOSCIENCE WAS NOTIFIED OF THE HGH AND LH II INCORRECT RESULTS. TOSOH BIOSCIENCE TECH SUPPORT SPECIALIST (TSS) REQUESTED ANALYZER PRINTOUTS/DATA FOR THE QCS FOR THE INVOLVED RUNS, ORIGINAL PATIENT RESULTS, AND REPEAT PATIENT RESULTS. THE CUSTOMER WAS ALSO ASKED TO DO PRECISION TESTING ON HGH AND LH II WITH THE CUSTOMER CONTROLS. CUSTOMER WAS TOLD THAT A TOSOH BIOSCIENCE FIELD SERVICE ENGINEER WOULD CALL TO DISCUSS SERVICE. ON 10/17/1206 FOLLOWING DATA RECEIVED BY TOSOH BIOSCIENCE TECHNICAL SUPPORT SPECIALIST. (B)(6) 2016 QC DATA, AIA TEST CUP LOTS F916662 AND G216664. ALL QC DATA WITHIN TARGET RANGE. HGH, PRECISION N = 15 AIA HGH TEST CUP LOT F916662, BIORAD QC1 LOT 40301 = 2.4% CV, OBSERVED MEAN = 3.33 NG/ML, TARGET MEAN = 3.2 NG/ML. LH II: PRECISION N = 15 LH II AIA TEST CUP LOT G713933, BIORAD QC1 LOT 40301 = NO CV INDICATED, OBSERVED MEAN = 1.297 MIU/ML, TARGET MEAN = 1.21 MIU/ML. (B)(6) 2016 LH II QC DATA RECEIVED. QC DATA WITHIN TARGET RANGE. QC BIORAD LOT 40301 = 1.21 MIU/ML, QC BIORAD LOT 40303 = 67.88 MIU/ML. ON 10/21/2016 TOSOH BIOSCIENCE FIELD SERVICE ENGINEER CONTACTED CUSTOMER ABOUT PROBLEMS AND CUSTOMER REFUSED SERVICE AT THAT TIME. ROOT CAUSE: UNABLE TO DETERMINE SINCE SERVICE WAS REFUSED AND ADDITIONAL INVESTIGATION COULD NOT BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748425 TOSOH AIA-1800 A1A-1800 KHO TOSOH CORPORATION 1800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other