BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY LACTATE DEHYDROGENASE

    MDR report key: 6549271 · Received May 5, 2017

    Report

    Report Number
    1628664-2017-00186
    Event Type
    Malfunction
    Date Received
    May 5, 2017
    Report Date
    May 5, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CFJ
    UDI-DI
    00380740004033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO RELATED ADVERSE OR NON-STATISTICAL TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION FOR THIS PRODUCT. THE ARCHITECT CLINICAL CHEMISTRY LACTATE DEHYDROGENASE REAGENT ASSAY INSERT AND THE ARCHITECT OPERATIONS MANUAL CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. AS THE REAGENT LOT HAS EXPIRED, NO TESTING WAS PERFORMED. BASED ON THE INFORMATION OBTAINED THROUGH THIS EVALUATION AND THE INFORMATION FROM THE CUSTOMER SITE, THERE IS EVIDENCE TO REASONABLY SUGGEST THAT A PRODUCT MALFUNCTION OCCURRED. HOWEVER, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED. LOT/SERIAL NUMBER WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE; THEREFORE, ONLY A DI IS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS FALSELY ELEVATED CLIN CHEM LDH ASSAY RESULTS BEING GENERATED ON PATIENT SAMPLES TESTED ON THE ARCHITECT C8000 ANALYZER. CONTROLS TREND HIGH BUT STILL WITHIN SPECIFICATIONS. PROFICIENCY SAMPLES HAVE ALWAYS PASSED. THE CUSTOMER USES SERUM PATIENT SAMPLES AND ALWAYS RUNS SAMPLES IN A 1:3 DILUTION. THE CUSTOMER NOTES THAT WHEN THE SAMPLES ARE RETESTED THE FOLLOWING DAY, VALUES DROP SIGNIFICANTLY INTO THE NORMAL REFERENCE RANGE (12% TO 47% DECREASE). WHEN USING REAGENT LOT 11911UN15, THE CUSTOMER REPORTED THE FOLLOWING VALUES (DAY 1, DAY 2): SAMPLE 1: 277, 243 U/L; SAMPLE 2: 336, 189 U/L; SAMPLE 3: 679, 536 U/L; SAMPLE 4: 171, 149 U/L; AND SAMPLE 5: 200, 176 U/L. THESE SAME TYPES OF RANGES WERE SEEN ON A SECOND ARCHITECT CSYSTEM IN THE LAB. THE CUSTOMER USES A NORMAL REFERENCE RANGE OF 125 - 220 U/L. SOME RESULTS HAVE BEEN QUESTIONED BY PHYSICIANS AS BEING HIGHER THAN EXPECTED. THERE IS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330688 CLINICAL CHEMISTRY LACTATE DEHYDROGENASE LACTATE DEHYDROGENASE CFJ ABBOTT MANUFACTURING INC 11911UN15 00380740004033

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C8000 ANALYZER LN: 01G06-01| SN: (B)(4)