BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTATE DEHYDROGENASE

    MDR report key: 10176543 · Received June 19, 2020

    Report

    Report Number
    3016438761-2020-00098
    Event Type
    Malfunction
    Date Received
    June 19, 2020
    Date of Event
    May 22, 2020
    Report Date
    July 8, 2020
    Manufacturer
    ABBOTT LABORATORIES (IRVING IA/CC)
    Product Code
    CFJ
    UDI-DI
    00380740004033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF COMPLAINT ACTIVITY ASSOCIATED WITH THE COMPLAINT LOT IDENTIFIED NORMAL COMPLAINT ACTIVITY. REVIEW OF TRACKING AND TRENDING REPORTS FOR THE LACTATE DEHYDROGENASE (LDH) REAGENT DID NOT IDENTIFY ANY RELATED TRENDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. USING WORLDWIDE FIELD DATA, THE PERFORMANCE OF REAGENT LOT 52827UN19, AND ASSOCIATED SUBLOTS, MANUFACTURED WITH THE SAME MATERIAL WERE EVALUATED AND ARE PERFORMING SIMILAR TO OTHER REAGENT LOTS IN THE FIELD CONFIRMING THERE WAS NO SYSTEMIC ISSUE. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOTS WERE REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE LACTATE DEHYDROGENASE (LDH) REAGENT WAS IDENTIFIED. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. CORRECTING SECTION D2. PRODUCT CODE FROM CFG TO CFJ.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER COMPLETE ENTRY = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULTS ON ONE PATIENT FROM AN ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2020, WAS 2441 U/L, WHICH WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE MEDICAL PROVIDER. WHEN THE SAMPLE WAS REPEATED THE RESULTS WERE 308, 369, 359, AND 312 U/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638073 LACTATE DEHYDROGENASE LACTATE DEHYDROGENASE CFJ ABBOTT LABORATORIES (IRVING IA/CC) 2P56-21 52827UN19 00380740004033

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C8000 PROCESSING MODULE,| ARCHITECT C8000 PROCESSING MODULE,| LIST# 01G06-11, SERIAL# (B)(6)| LIST# 01G06-11, SERIAL# (B)(6)