BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXC 700 AU CHEMISTRY ANALYZER

    MDR report key: 14017823 · Received April 5, 2022

    Report

    Report Number
    9612296-2022-00124
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    March 11, 2022
    Report Date
    April 5, 2022
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    14987666542545
    PMA / PMN Number
    K161837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE DXC 700 AU CHEMISTRY ANALYZER, AND IDENTIFIED THE FAILURE MODE AS MULTIPLE HARDWARE. THE FSE REPLACED THE SAMPLE DISPENSE UNIT, DEIONIZED WATER DISPENSE VALVE, AND GEAR CONTROL PRINTED CIRCUIT BOARD WHICH RESOLVED THE ISSUE. INFORMATION NOT PROVIDED BY CUSTOMER. THE BECKMAN COULTER INTERNAL IDENTIFIER IS CASE-(B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE GENERATION OF INTERMITTENT ERRONEOUSLY LOW, ZERO, OR NEGATIVE RESULTS FOR MULTIPLE ANALYTES, INCLUDING, SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), BICARBONATE (CO2), ALBMIN (ALB), BLOOD UREA NITROGEN (BUN), ALKALINE PHOSTATASE (ALP), ASPARTATE AMINOTRANSFERASE (AST), ALANINE AMINOTRANSFERASE (ALT), GLUCOSE (GLU), MAGNESIUM (MG), CALCIUM (CALA), TOTAL PROTEIN (TP), AND CREATININE (CRE)) ON THEIR DXC 700 AU CHEMISTRY ANALYZER. CUSTOMER REPORTED THE SAMPLES HAD G, J, K, PL, AND FH FLAGS. RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS 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
    841235 DXC 700 AU CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 700 AU-10E CHEMISTRY ANALYZER DXC 700 AU WITH ISE 14987666542545

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown