BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY LACTATE DEHYDROGENASE

    MDR report key: 6995744 · Received November 2, 2017

    Report

    Report Number
    1628664-2017-00414
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    October 16, 2017
    Report Date
    November 2, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CFJ
    UDI-DI
    00380740004033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD TECHNICIAN VISITED THE CUSTOMER SITE TO REVIEW THE ISSUE WITH THE CUSTOMER. THE REAGENT WAS REPLACED AND PLACED IN A DIFFERENT POSITION ON THE ANALYZER. THE WATER QUALITY WAS CHECKED AND FOUND TO BE ACCEPTABLE. THE SAMPLE DILUENT WAS ALSO REPLACED AND THE CUSTOMER INFORMED TO REPLACE DAILY. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE. INSTRUMENT LOGS AND HISTORY FILES WERE REVIEWED AS STORED IN THE ARCHITECT C16000 ANALYZER FOR THE CLIN CHEM LDH ASSAY. THE ASSAY CURVE PATTERN WAS UNREMARKABLE AND SIMILAR TO OTHER CURVES. FROM (B)(6) 2017, SIXTY INSTANCES OF ASPIRATION ERROR CODES WERE LOGGED ALONG WITH TWENTY-FOUR INSTANCES OF INCOMPLETE CUVETTE WASHING ERROR CODES. SAMPLE HANDLING AND/OR SAMPLE INTEGRITY ISSUES CANNOT BE RULED OUT AS POSSIBLE CAUSES OF THE CUSTOMER ISSUE AS WELL AS INCOMPLETE INSTRUMENT MAINTENANCE. THE ARCHITECT CLINICAL CHEMISTRY LDH ASSAY PACKAGE INSERT AND THE ARCHITECT OPERATIONS MANUAL CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A SYSTEMIC ISSUE OR PRODUCT DEFICIENCY EXISTS.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE FOLLOWING ARCHITECT CLIN CHEM ASSAY RESULTS WERE GENERATED ON AN ARCHITECT C16000 ANALYZER: (B)(6): INITIAL RESULT OF 237 U/L THAT RETESTED AT 191 U/L. (B)(6): INITIAL RESULT OF 279 U/L THAT RETESTED AT 207 U/L. THE CUSTOMER USES A NORMAL REFERENCE RANGE OF 125 TO 220 U/L. THE CUSTOMER WILL BEGIN TESTING ALL SAMPLES FOR LDH IN DUPLICATE. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT CARE REPORTED. A SERVICE CALL WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777175 CLINICAL CHEMISTRY LACTATE DEHYDROGENASE LACTATE DEHYDROGENASE CFJ ABBOTT MANUFACTURING INC 2P56-21 36251UN17 00380740004033

    Patients

    Seq Age Sex Outcome Treatment
    1