BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU600 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2617000 · Received June 14, 2012

    Report

    Report Number
    2050012-2012-01262
    Event Type
    Malfunction
    Date Received
    June 14, 2012
    Date of Event
    May 22, 2012
    Report Date
    May 25, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MZV
    PMA / PMN Number
    K961274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. BECKMAN COULTER TECHNICAL SUPPORT RECOMMENDED THAT THE CUSTOMER REPLACE THE ION-SELECTIVE ELECTRODE ROLLER PUMP TUBING. THE EVENT HAS NOT RECURRED. THE FAILURE MODE FOR THIS EVENT WAS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS LOW POTASSIUM (K) RESULTS OF LESS THAN TWO MMOL/L WERE GENERATED FROM AN AU600 CLINICAL CHEMISTRY ANALYZER FOR TWO PATIENTS. ACTUAL PATIENT DATA WAS NOT PROVIDED BY THE CUSTOMER AND HENCE THE DATE OF OCCURRENCE, NUMBER OF PATIENTS INVOLVED AND THE ACTUAL PATIENT RESULTS COULD NOT BE CONFIRMED. UPON REPEAT, THE K REPEAT RESULTS RECOVERED WITHIN THE NORMAL RANGE OF THE CHEMISTRY. THE LOW K RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. INSTRUMENT CHEMISTRY QUALITY CONTROL RESULTS WERE WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS DURING THE TIMEFRAME OF THE EVENT. NO SPECIFIC PATIENT INFORMATION OR SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU600 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MZV BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1