BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7918192 · Received September 28, 2018

    Report

    Report Number
    8031673-2018-00882
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    September 7, 2018
    Report Date
    September 28, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM 07-AUG-2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SAFETY PRECAUTIONS, STATES: OPERATE ONLY IN ACCORDANCE WITH THE PROCEDURES DESCRIBED IN THIS MANUAL. ATTEMPTS TO OPERATE THE AIA-900 USING PROCEDURES NOT PRESCRIBED IN THIS MANUAL MAY. ADVERSELY AFFECT THE INTEGRITY OF ASSAY RESULTS AND CAUSE SYSTEM MALFUNCTIONS. THE ST AIA PACK ESTRADIOL (E2) ANALYTE APPLICATION MANUAL STATES THE FOLLOWING UNDER SPECIMEN COLLECTION AND HANDLING: SERUM OR HEPARINIZED PLASMA IS REQUIRED FOR THE ASSAY. EDTA AND CITRATED PLASMA SHOULD NOT BE USED. NO SPECIAL PATIENT PREPARATION IS NECESSARY. WHEN USING SERUM, A VENOUS BLOOD SAMPLE IS COLLECTED ASEPTICALLY WITHOUT ADDITIVES (RED TOP TUBE). STORE AT 18-25°C UNTIL A CLOT HAS FORMED (USUALLY 15 - 45 MINUTES), THEN CENTRIFUGE TO OBTAIN THE SERUM SPECIMEN FOR ASSAY. SST OR GEL TUBES HAVE NOT BEEN VALIDATED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO OPERATOR ERROR OF THE CUSTOMER USING NON-VALIDATED SERUM SEPARATOR TUBES.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THEY OBTAINED TWO DIFFERENT ESTRADIOL (E2) VALUES WHEN RUNNING A REPEAT SPECIMEN ON THE AIA-900 INSTRUMENT. THE CUSTOMER REPORTED THAT THE INITIAL RESULTS WERE HIGHER THAN THE REPEATED RESULT, WHICH WAS LOWER. THE QUALITY CONTROLS (QC) WERE IN RANGE AND THERE WERE NO ANALYZER ISSUES NOTED. THE CUSTOMER REPORTED THAT THEY WERE USING E2 LOT I212903 AND SERUM SEPARATOR TUBE (SST) ARE PLACED ON THE ANALYZER. THE SERUM REMAINED IN THE SST TUBES FOR THE SECOND RUN. TECHNICAL SUPPORT (TSS) INFORMED THE CUSTOMER THAT THE SST GEL TUBES HAVE NOT BEEN VALIDATED BY TOSOH AND THAT SERUM FROM THE PLAIN RED TOP TUBES ARE REQUIRED. ADDITIONALLY, THE GEL IN THE SST TUBES MAY POTENTIALLY ABSORB PROTEIN CAUSING DECREASED RESULTS AS THE SERUM SITS ON THE GEL. THE CUSTOMER RUNS E2 PATIENT SAMPLES ONE (1) HOUR AFTER THE DRAW AND REPEAT SAMPLES 3-4 HOURS AFTER THE DRAW. THE CUSTOMER REPORTED THAT THEY HAVE ONLY BEEN REPORTING OUT THE INITIAL RUN RESULT. TSS ADVISED THE CUSTOMER TO EITHER VALIDATE THE SST TUBES OR TO USE THE PLAIN RED TOPS ONLY. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761402 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1