BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU680 CHEMISTRY ANALYZER

    MDR report key: 22311996 · Received June 23, 2025

    Report

    Report Number
    9612296-2025-00802
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    May 31, 2025
    Report Date
    June 23, 2025
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    UDI-DI
    14987666540725
    PMA / PMN Number
    K961274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) REMOTELY ASSISTED THE CUSTOMER WITH THE AU680 CHEMISTRY ANALYZER AND IDENTIFIED THAT THE R1 SYRINGE WAS LOOSE. THE CUSTOMER REPLACED THE R1 AND R2 SYRINGES WHICH RESOLVED THE ISSUE. SECTION A2, A4 AND A5: INFORMATION NOT PROVIDED BY CUSTOMER. THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY LOW PATIENT RESULTS FOR MULTIPLE ANALYTES WHICH INCLUDES CMP (COMPREHENSIVE METABOLIC PANEL) AND BMP (BASIC METABOLIC PANEL) WITH ¿D¿ ¿G¿ ¿L¿ ¿K¿ FLAGS AND FALSE POSITIVE RESULTS FOR DAU (DRUG OF ABUSE) WHICH INCLUDES BARB (BARBITURATES), BENZ (BENZODIAZEPINE), CANNABINOID (THC), OPIATE (OPIA) WITH ¿P¿ FLAG ON THEIR AU680 CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER STATED TWO (2) FALSE POSITIVE PATIENT RESULTS WERE REPORTED OUT OF LABORATORY AND WERE LATER AMENDED. THE LOW ERRONEOUS CHEMISTRY PATIENT RESULTS WERE NOT REPORTED OUT OF LABORATORY. THE CUSTOMER CONFIRMED THAT ISE (ION SELECTIVE ELECTRODE) PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS. THE CUSTOMER PROVIDED DATA FOR THREE (3) PATIENT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063371 AU680 CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. AU681-10E CHEMISTRY ANALYZER AU680 WITH ISE 14987666540725

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown