BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 8259219 · Received January 17, 2019

    Report

    Report Number
    8031673-2018-05430
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    October 10, 2018
    Report Date
    September 18, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR SERIAL NUMBER 10597511, WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE ADJUSTED THE SEAL BREAKER AND DETECTOR HOME POSITIONS, DECONTAMINATED THE WASH AND DILUENT LINES WITH BLEACH, AND THEN VERIFIED ALL THE OTHER SYSTEMS AND TEMPERATURES FSE WAS SUBSEQUENTLY ABLE TO PERFORM CALIBRATION, QUALITY CONTROL (QC), AND PRECISION WITHOUT ISSUE. THE FOLLOWING DAY, WHEN THE CUSTOMER STARTED UP QC FOR E2 WAS OUT ON TWO LEVELS. THE CUSTOMER WAS INSTRUCTED TO RECALIBRATE USING E2 CUP LOT #15, CALIBRATION LOT #1732984. E2- BIORAD 40351: LEVEL 1: 264 (RANGE 264-300). E2- BIORAD 40353: LEVEL 3: 1344 (RANGE 1249-1403). E2- MAC, LOT# H706, LEVEL 1: 165 (RANGE 116.6-216.6), LEVEL 3: 409 (RANGE 271.4-504.1). ALL ASSAYS WERE NOW IN RANGE ON BOTH BIORAD AND MAC CONTROLS. THE CUSTOMER WAS INSTRUCTED TO RERUN THEIR API PROFICIENCY WITH THE NEW CALIBRATION VALUES. NO FURTHER ISSUES WERE NOTED. NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO PERFORMANCE EVALUATION, DECONTAMINATION, AND MISALIGNMENT OF THE SEAL BREAK AND THE DETECTOR. 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.

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THE DEVICE WAS INSTALLED AT THE SITE ON (B)(6) 2018. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(6) FROM 14JUN2018 THROUGH AWARE DATE (B)(4) 2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE IRI AND FSH AIA-PACK PACKAGE INSERTS STATE THE FOLLOWING: 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. TO USE HEPARINIZED PLASMA, A VENOUS BLOOD SAMPLE IS COLLECTED ASEPTICALLY WITH THE DESIGNATED ADDITIVE. CENTRIFUGE AND SEPARATE PLASMA FROM THE PACKED CELLS AS SOON AS POSSIBLE. SAMPLES MAY BE STORED AT 2° - 8° C FOR UP TO 24 HOURS PRIOR TO ANALYSIS. IF THE ANALYSIS CANNOT BE DONE WITHIN 24 HOURS, THE SAMPLE SHOULD BE STORED FROZEN AT -20°C OR BELOW FOR UP TO 60 DAYS. REPEATED FREEZE-THAW CYCLES SHOULD BE AVOIDED. TURBID SERUM SAMPLES OR SAMPLES CONTAINING PARTICULATE MATTER SHOULD BE CENTRIFUGED PRIOR TO TESTING. PRIOR TO ASSAY, SLOWLY BRING FROZEN SAMPLES TO ROOM TEMPERATURE (18° - 25° C) AND MIX GENTLY. THE SAMPLE REQUIRED FOR ANALYSIS IS 50 MICROLITERS. THE FSH AIA-PACK PACKAGE INSERT STATES THE FOLLOWING: SPECIMEN COLLECTION AND HANDLING. SERUM OR HEPARINIZED PLASMA IS REQUIRED FOR THE ASSAY. EDTA AND CITRATED PLASMA SHOULD NOT BE USED. SINCE PHYSICAL OR EMOTIONAL STRESS MAY ELEVATE BLOOD LEVELS OF PROLACTIN, PATIENTS SHOULD BE UNDER RESTING BASAL CONDITIONS PRIOR TO SAMPLING. ALSO, PROLACTIN LEVELS RISE RAPIDLY WITH SLEEP, SO SAMPLES IDEALLY SHOULD NOT BE TAKEN UNTIL 1 - 2 HOURS AFTER AWAKENING. PROLACTIN, LIKE OTHER PITUITARY HORMONES, IS SECRETED EPISODICALLY; IT MAY BE ADVANTAGEOUS TO POOL EQUAL VOLUMES OF TWO OR MORE SERA FROM SAMPLES DRAWN AT 6 - 18 MINUTE INTERVALS. 12. 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. TO USE HEPARINIZED PLASMA, A VENOUS BLOOD SAMPLE IS COLLECTED ASEPTICALLY WITH THE DESIGNATED ADDITIVE. CENTRIFUGE AND SEPARATE PLASMA FROM THE PACKED CELLS AS SOON AS POSSIBLE. SAMPLES MAY BE STORED AT 2° - 8° C FOR UP TO 24 HOURS PRIOR TO ANALYSIS. IF THE ANALYSIS CANNOT BE DONE WITHIN 24 HOURS, THE SAMPLE SHOULD BE STORED FROZEN AT -20° C OR BELOW FOR UP TO 60 DAYS. REPEATED FREEZE-THAW CYCLES SHOULD BE AVOIDED. TURBID SERUM SAMPLES OR SAMPLES CONTAINING PARTICULATE MATTER SHOULD BE CENTRIFUGED PRIOR TO TESTING. PRIOR TO ASSAY, SLOWLY BRING FROZEN SAMPLES TO ROOM TEMPERATURE (18° - 25° C) AND MIX GENTLY. THE SAMPLE REQUIRED FOR ANALYSIS IS 30 MICROLITERS. THE PTH AIA-PACK PACKAGE INSERT STATES THE FOLLOWING: SPECIMEN COLLECTION AND HANDLING SERUM, EDTA PLASMA IS REQUIRED FOR THE ASSAY. HEPARINIZED OR CITRATED PLASMA SHOULD NOT BE USED. 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. IF USING EDTA PLASMA, A VENOUS BLOOD SAMPLE IS COLLECTED ASEPTICALLY WITH DESIGNATED ADDITIVE (10-11). CENTRIFUGE AND SEPARATE PLASMA FROM THE PACKED CELLS AS SOON AS POSSIBLE. SPECIMEN TYPES SHOULD NOT BE USED INTERCHANGEABLY DURING THE SERIAL MONITORING OF AN INDIVIDUAL PATIENT. MEASURED CONCENTRATIONS MAY VARY SLIGHTLY BETWEEN SAMPLE TYPES IN CERTAIN PATIENTS. SPECIMEN MAY BE STORED AT 2-8°C FOR UP TO 24 HOURS PRIOR TO ANALYSIS. IF THE ANALYSIS CANNOT BE DONE WITHIN 24 HOURS, THE SAMPLE SHOULD BE STORED FROZEN AT -20°C OR BELOW FOR UP TO 60 DAYS. REPEATED FREEZE-THAW CYCLES SHOULD BE AVOIDED. TURBID SERUM SAMPLES OR SAMPLES CONTAINING PARTICULATE MATTER SHOULD BE CENTRIFUGED PRIOR TO TESTING. PRIOR TO ASSAY, BRING FROZEN SAMPLES TO 18-25°C SLOWLY AND MIX GENTLY. THE SAMPLE REQUIRED FOR ANALYSIS IS 75 MICROLITERS. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS STILL BEING INVESTIGATED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FAILURE OF FOLLICLE STIMULATING HORMONE (FSH), PROLACTIN (PRL), INSULIN (IRI), AND PARATHYROID HORMONE (PTH) ANALYTES ON (B)(6) 2018 AMERICAN PROFICIENCY INSTITUTE (API) TESTING FOR THEIR AIA-2000ST ANALYZER. THE CUSTOMER STATED THAT QUALITY CONTROL (QC) FOR ALL FOUR ANALYTES HAD BEEN NEAR THE MEAN THAT DAY. THE CUSTOMER FURTHER STATED THAT THEY REFRIGERATED THE SAMPLES FOR TEN DAYS AND HAD NOT FROZEN THEM TO RERUN. TS FOLLOWED UP WITH THE CUSTOMER AGAIN APPROXIMATELY TWO WEEKS LATER. TS INSTRUCTED THE CUSTOMER TO RUN TWENTY SAMPLES ON IRI, CV%=4.8. THE CUSTOMER BELIEVED THERE MAY BE A GREATER ISSUE WITH PRECISION WHEN THE WASH WAS LOW AND FAXED AN EXAMPLE FROM NOVEMBER FOR TS TO REVIEW. NEXT, TS INSTRUCTED THE CUSTOMER TO RUN TOSOH CUPS TO SEE IF THIS RESOLVED THE ISSUE. IF THE CUSTOMER NOTED A QC DRIFT WHEN THE WASH WAS LOW, TS THEN ADVISED THE CUSTOMER TO MAKE FRESH WASH, PRIME AND RERUN THE SAME QC. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51841 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1