BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2981758 · Received February 27, 2013

    Report

    Report Number
    2050012-2013-00124
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE BY TIGHTENING THE CARTRIDGE CHEMISTRY SAMPLE SYRINGE. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED (B)(6) RESULTS, FOR TWO PATIENTS, INVOLVING THE UNICEL DXC 800 SYNCHRON SYSTEM. ALANINE AMINOTRANSFERASE (ALT), ASPARTINE AMINOTRANSFERASE (AST), TRIGLYCERIDES (TG) AND MAGNESIUM (MG) RESULTS WERE SUPPRESSED WITH BLANK ERRORS FOR AN UNKNOWN NUMBER OF SAMPLES. SUBSEQUENT ANALYSES OF THE PATIENTS' SAMPLES, ON AN ALTERNATE UNICEL DXC 800 SYSTEM, RECOVERED HIGHER PRE-ALBUMIN RESULTS FOR BOTH PATIENTS. PATIENT (B)(6) OBTAINED AN INITIAL (B)(6) RESULT OF (B)(6) AND A REANALYZED VALUE OF (B)(6). PATIENT (B)(6) OBTAINED AN INITIAL RESULT OF (B)(6) AND A REANALYZED VALUE OF (B)(6). THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY. IT IS UNKNOWN IF PATIENT TREATMENT WAS IMPACTED. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND VERIFIED THE CARTRIDGE CHEMISTRY SAMPLE SYRINGE TO BE SLIGHTLY LOOSE. THE CUSTOMER STATED QUALITY CONTROL (QC) WAS WITHIN THE ACCEPTABLE RANGE ON THE DAY OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83653 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1