BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 9803581 · Received March 7, 2020

    Report

    Report Number
    8031673-2020-00045
    Event Type
    Malfunction
    Date Received
    March 7, 2020
    Date of Event
    February 10, 2020
    Report Date
    March 18, 2020
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. FSE ARRIVED ONSITE TO ADDRESS THE REPORTED EVENT. FSE CONFIRMED THE ISSUE BY REVIEWING THE CUSTOMER'S PRINTOUTS AND REPRODUCED THE ISSUE BY RUNNING A PATIENT SAMPLE. NEXT, FSE REPLACED THE WASH PROBE AND VERIFIED ALIGNMENTS WERE WITHIN SPECIFICATIONS. FSE ALSO DECONTAMINATED THE SYSTEM DUE TO SUSPECTED CONTAMINATION AND UPGRADED THE SOFTWARE PER THE T187 BULLETIN. NO FURTHER ISSUES WERE NOTED. NO FURTHER ACTION AS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILURE OF THE WASH PROBE AND SYSTEM CONTAMINATION.

    Additional Manufacturer Narrative · 1

    INITIALLY, FSE WORKED WITH THE CUSTOMER OVER THE PHONE TO PERFORM DECONTAMINATION OF THE ANALYZER. THE CUSTOMER RAN E2 WITH DI AND RECEIVED THE RESULT 74.2PG/M. NEXT, THE CUSTOMER SENT IN THE FROZEN SAMPLES TO BE TESTED IN THE QUALITY ASSURANCE (QA) LAB. SEVERAL DAYS LATER FSE ARRANGED TO GO ONSITE AS THE ISSUE WAS STILL ONGOING. A 13-MONTH COMPLAINT SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM 10JAN2019 THROUGH AWARE DATE 10FEB2020. THERE WAS TWO SIMILAR COMPLAINTS, INCLUDING THIS ONE, IDENTIFIED DURING THE SEARCHED PERIOD. A 13- MONTH LOT-SERIAL NUMBER SPECIFIC HISTORY REVIEW WAS PERFORMED FOR E2 LOT J912944 FROM 10JAN2019 THROUGH AWARE DATE 10FEB2020. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE ST AIA-PACK E2 ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: LIMITATIONS OF THE PROCEDURE: FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD BE USED IN CONJUNCTION WITH OTHER DATA (E.G. SYMPTOMS, RESULTS OF OTHER TESTS, CLINICAL IMPRESSIONS, THERAPY, ETC.). EXPECTED VALUES: EACH LABORATORY SHOULD DETERMINE A REFERENCE INTERVAL CORRESPONDING TO THE CHARACTERISTICS OF THE POPULATION BEING TESTED. AS WITH ALL DIAGNOSTIC PROCEDURES, CLINICAL RESULTS MUST BE INTERPRETED WITH REGARD TO CONCOMITANT MEDICATIONS ADMINISTERED TO THE PATIENT. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS STILL BEING INVESTIGATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING DISCREPANT RESULTS ON TWO PATIENT SAMPLES FOR ESTRADIOL (E2) ON THEIR AIA-360 ANALYZER. THE RESULT FOR ONE SAMPLE WAS 64 AND 68.3 ON THE OTHER USING E2 LOT # J912944 AND CALIBRATOR LOT #J632989. THE CUSTOMER ALSO SENT THE SAME SAMPLE OUT TO A REFERENCE LAB AND RECEIVED RESULTS OF <0.05 FOR BOTH. THE CUSTOMER STATED THAT THE SAMPLES WERE NOT FROZEN PRIOR TO SENDING THEM TO THE REFERENCE LAB. THE CUSTOMER ALSO STATED THAT NEITHER PATIENT WAS ON ANY OTHER SUPPLEMENT OTHER THAN THE ORAL E2 INHIBITOR SO BIOTIN INTERFERENCE WAS RULED OUT. THESE WERE THE ONLY TWO PATIENTS REPORTED. THERE WAS NO SIMILAR ISSUE WITH ANY OTHER ANALYTE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. 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
    266980 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1