BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU480 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 21785362 · Received April 7, 2025

    Report

    Report Number
    9612296-2025-00668
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 12, 2025
    Report Date
    April 7, 2025
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K981743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE AU480 CHEMISTRY ANALYZER. THE FSE INSPECTED THE ANALYZER AND FOUND WORN ANTISTATIC BRUSH, MISALIGNED SAMPLE PROBE, AND DEFECTIVE LEVEL SENSE PCB (PRINTED CIRCUIT BOARD) THE FSE IDENTIFIED THE FAILURE AS DEFECTIVE ANTISTATIC BRUSH AND LEVEL SENSE PRINTED CIRCUIT BOARD (PCB). THE FSE REPLACED THE LEVEL SENSE PCB, ANTISTATIC BRUSH, AND REALIGNED THE SAMPLE PROBE TO RESOLVE THE ISSUE. SYSTEM PERFORMANCE WAS VERIFIED. SECTION A2, A4, AND A5: INFORMATION NOT PROVIDED BY CUSTOMER. SECTION E1, INITIAL REPORTER TELEPHONE (B)(6). THE BECKMAN COULTER IDENTIFIER IS CASE-(B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUS LOW/NEGATIVE PATIENT RESULTS WITH ¿G¿ AND ¿K¿ FLAGS ON MULTIPLE CHEMISTRIES WHICH INCLUDED SODIUM (NA), POTASSIUM (K) , CHLORIDE (CL), ALANINE AMINOTRANSFERASE (ALT), ALKALINE PHOSPHATASE (ALP), ASPARTATE AMINOTRANSFERASE (AST), BICARBONATE (CO2), LIPASE (LIP), TOTAL BILIRUBIN (TBIL), CREATININE (CREA), GAMMA-GLYTAMYL TRANSFERASE (GGT), TOTAL PROTEIN (TP), UREA, AND ALBUMIN (ALB) ON THEIR AU480 CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER PROVIDED EXAMPLE OF FALSE RESULTS FOR TWO (2) PATIENTS,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655359 AU480 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. AU481-10E CHEMISTRY ANALYZER AU480 WITH ISE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown