BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTATE DEHYDROGENASE

    MDR report key: 7024630 · Received November 13, 2017

    Report

    Report Number
    1628664-2017-00435
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 20, 2017
    Report Date
    November 21, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, INSTRUMENT LOG REVIEW, AND A REVIEW OF LABELING. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS RELATED TO THE COMPLAINT ISSUE. INSTRUMENT LOGS AND HISTORY FILES THAT WERE STORED ON THE CUSTOMER'S ARCHITECT C8000 ANALYZER WERE REVIEWED. THE ASSAY CURVE PATTERN FOR THE QUESTIONED SAMPLE ID WAS UNREMARKABLE AND SIMILAR TO OTHER CURVES. REVIEW OF THE INSTRUMENT HISTORY LOG FROM (B)(6) 2017 TO (B)(6) 2017 FOUND 543 INSTANCES OF ASPIRATION ERROR CODES AND SEVENTY-FIVE 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. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE AVAILABLE INFORMATION AND THIS EVALUATION, NO SYSTEMIC ISSUE AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE ELEVATED ARCHITECT LACTATE DEHYDROGENASE RESULT FROM ONE PATIENT. SAMPLE (B)(6) GENERATED AN INITIAL RESULT OF 419 U/L AND RETEST RESULT OF 199 U/L. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804727 LACTATE DEHYDROGENASE LACTATE DEHYDROGENASE CFJ ABBOTT MANUFACTURING INC 66794UN16

    Patients

    Seq Age Sex Outcome Treatment
    1