BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5800 CHEMISTRY ANALYZER

    MDR report key: 9613448 · Received January 21, 2020

    Report

    Report Number
    9680746-2020-00001
    Event Type
    Malfunction
    Date Received
    January 21, 2020
    Date of Event
    November 28, 2019
    Report Date
    January 21, 2020
    Manufacturer
    BECKMAN COULTER IRELAND
    Product Code
    JJE
    UDI-DI
    15099590010737
    PMA / PMN Number
    K924692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER COMPLAINT HANDLING UNIT PERFORMED REVIEW OF THE REACTION MONITORS. THERE IS NO EVIDENCE OF SAMPLE DISPENSING, REAGENT DISPENSING/MIXING OR PHOTOMETRIC ISSUE. THE REACTION PROFILES ARE AS EXPECTED. THERE WAS NO REPORT OF SAMPLE INTEGRITY. ONLY ONE (1) PATIENT SAMPLE WAS AFFECTED BY THIS EVENT. THERE IS EVIDENCE OF A REAGENT MALFUNCTION AS DISCREPANT RESULTS WERE OBTAINED WITH CREATININE OSR6178 APPLICATION. THIS IS A PATIENT SPECIFIC ISSUE. THE BATCH HISTORY RECORDS WERE REVIEWED FOR OSR6178 LOT 2599. THE BATCH PASSED ALL QUALITY CONTROL (QC) RELEASE SPECIFICATIONS. A COMPLAINT SEARCH WAS PERFORMED. NO OTHER COMPLAINT HAS BEEN LOGGED FOR OSR6178 LOT 2599; THEREFORE, THIS ISSUE IS NOT CREATININE LOT SPECIFIC ISSUE. THE DISCREPANCY IN RESULTS IS MOST LIKELY CAUSE BY AN UNKNOWN INTERFERENCE. THE PATIENT MEDICATION HISTORY WAS REQUESTED WHICH INDICATED THE PATIENT WAS TREATED WITH FUROSEMIDE (20 MG PER DAY), BISOPROLOL, LERCANIDIPINE, ALPRAZOLAM AND PREVISCAN. PER YOUNG, D.S., EFFECTS OF DRUGS ON CLINICAL LABORATORY TESTS, AACC PRESS, 5TH EDITION 2000: BISOPROLOL, LERCANIDIPINE, ALPRAZOLAM AND PREVISCAN AND LOW DOSES OF FUROSEMIDE (<30 MG/DL) ARE NOT REPORTED TO HAVE ANY ANALYTICAL EFFECT ON THE CREATININE OSR6178 (COLOROMETRIC METHOD). BASED ON THE INFORMATION PROVIDED, THE INTERFERENT COULD NOT BE CONCLUSIVELY IDENTIFIED. INFORMATION NOT PROVIDED BY CUSTOMER. INITIAL REPORTER TELEPHONE NUMBER IS (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE GENERATION OF A FALSE LOW CREATININE RESULT FOR ONE (1) PATIENT SAMPLE ON THE AU5800 CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS PATIENT RESULT WAS REPORTED OUTSIDE THE LAB. DUE TO THE FALSE LOW CREATININE PATIENT RESULT, THE PATIENT WAS SCANNED AND RECEIVED AN INTRAVENOUS INJECTION OF IODINE CONTRAST AGENT. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77415 AU5800 CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER IRELAND CREATININE, R1 4 X 51 ML, R2 4 X 51 ML 2599 15099590010737

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown