BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 6950296 · Received October 13, 2017

    Report

    Report Number
    8031673-2017-00053
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    September 15, 2017
    Report Date
    September 19, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    PLEASE NOTE THAT THIS MDR MFR REPORT #: 8031673-2017-00053 / IMPORTER REPORT #: 3005529799-2017-00061 WAS PREVIOUSLY SUBMITTED TO THE FDA ON 28DEC2017; IT WAS RECREATED AS MFR REPORT #: 8031673-2017-00053 PER REQUEST BY THE FDA MDR DATA SYSTEMS TEAM REPRESENTATIVE. 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. CORRECTED DATA: SECTION G2: CHECKED "HEALTH CARE PROFESSIONAL" AS REPORT SOURCE INCORRECT NUMBERING MDR# 8031673-2017-00054 /IMPORTER REPORT #: 3005529799-2017-00062 WAS CORRECTED TO MFR REPORT #: 8031673-2017-00053.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) FOUND THE MAIN ARM SAMPLING NOZZLE CLOTTED WITH SERUM. THE FSE CLEANED THE SAMPLING NOZZLE, RAN DAILY BACKGROUND AND QUALITY CONTROLS. THE AIA-2000 WAS FUNCTIONING AS DESIGNED. A COMPLAINT HISTORY REVIEW FOR SERIAL NUMBER (B)(4) WAS PERFORMED FROM 15-AUG-2016 THROUGH 15-SEP-2017 FOR SIMILAR COMPLAINTS. NO OTHER SIMILAR COMPLAINTS WERE IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER SECTION A4. APPENDIX 4: ERROR MESSAGES STATES THE FOLLOWING: 2070 - CLOGGING DETECTED DURING SPECIMEN SUCTION BY MAIN ARM OCCURS WHEN THE NEGATIVE PRESSURE DETECTED AFTER SPECIMEN SUCTION EXCEEDS THE STANDARD. THE SPECIFIED AMOUNT OF SPECIMEN MAY NOT HAVE BEEN OBTAINED BECAUSE THE SAMPLING NOZZLE WAS BLOCKED. THE MEASUREMENT RESULT WILL BE FLAGGED (SC FLAG). THE OPERATOR IS INSTRUCTED TO VERIFY THAT THE SPECIMEN IS FREE OF SOLID SUBSTANCES (SUCH AS FIBRIN) OR THAT THERE IS SUFFICIENT VOLUME OF SPECIMEN IF IT IS PREPARED IN THE PRIMARY TUBE, AND RETRY THE MEASUREMENT. IF RETRY FAILS, CONTACT THE TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVE. 2071 - CLOGGING DETECTED DURING SPECIMEN DILUTION SOLUTION SUCTION BY MAIN ARM OCCURS WHEN CLOGGING IS DETECTED AFTER SPECIMEN DILUTING SOLUTION SUCTION. IF RETRY FAILS, THE MEASUREMENT RESULT WILL BE FLAGGED (LS FLAG). THE OPERATOR IS INSTRUCTED TO CONTACT THE TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A CLOGGED SAMPLING NOZZLE.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED GETTING 2070 - CLOGGING DETECTED DURING SPECIMEN SUCTION BY MAIN ARM AND 2071 - CLOGGING DETECTED DURING SPECIMEN DILUTION SOLUTION SUCTION BY MAIN ARM ERROR MESSAGES WHILE RUNNING PATIENT SAMPLES ON THE AIA-2000 ANALYZER. THE CUSTOMER IS UNABLE TO RUN PATIENT SAMPLES FOR FOLLICLE STIMULATING HORMONE (FSH), LUTEINIZING HORMONE (LH), AND INTACT PARATHYROID HORMONE (IPTH). ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR FSH, LH, AND IPTH. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727767 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown