BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2731227 · Received September 6, 2012

    Report

    Report Number
    2050012-2012-01710
    Event Type
    Malfunction
    Date Received
    September 6, 2012
    Date of Event
    August 17, 2012
    Report Date
    August 17, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    NQD
    PMA / PMN Number
    K962294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE TO ADDRESS THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE SAMPLE PROBE WASH CUP WAS ONLY PARTIALLY DRAINING. THE FSE REPLACED A SPECIFIC IN LINE FILTER WHICH RESOLVED THE ISSUE. THE INSTRUMENT WAS RETURNED BACK INTO OPERATION UPON THE COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS. THE CAUSE OF THE OVERFLOWING SAMPLE WASH STATION WAS A SPECIFIC PROBE RINSE FILTER

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: UPON FURTHER INVESTIGATION, BECKMAN COULTER HAS DETERMINED THAT THERE ARE NO CRITICAL CHEMISTRIES ANALYZED ON THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. UPON RECUR, THE MALFUNCTION WOULD NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS ALBUMIN (ALB) AND CARDIAC C-REACTIVE PROTEIN (CCRP) RESULTS WITHOUT INSTRUMENT GENERATED FLAGGING WERE GENERATED ON AN IMMAGE 800 IMMUNOCHEMISTRY SYSTEM FOR FOUR PATIENTS. ACTUAL PATIENT RESULTS WERE NOT PROVIDED BY THE CUSTOMER. THE ERRONEOUS PATIENT RESULTS WERE FOUND TO BE IN CONJUNCTION WITH THE OVERFLOWING OF A SAMPLE WASH STATION. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND HAD DRIPPED DOWN ONTO THE CABINET AND FLOOR. THE VOLUME OF THE LEAK WAS APPROXIMATELY FORTY TO FIFTY MILLILITERS. THE CUSTOMER VERBALLY INDICATED THAT ONE PATIENT'S INITIAL ALB VALUE WAS 300 MG/DL PRIOR TO DISCOVERY OF THE LEAK AND RECOVERED AT 400 MG/DL UPON RETEST AFTER THE LEAK HAD BEEN RESOLVED. ANOTHER PATIENT SAMPLE HAD A CCRP VALUE OF <0.4 MG/DL PRIOR TO DISCOVERY OF THE LEAK AND WHEN RETESTED FOLLOWING CORRECTION OF THE LEAK THE VALUE WAS 0.5 MG/DL. THESE RESULTS WERE REGARDED AS OUTSIDE THE PRECISION CLAIMS OF THE ASSAY. NO INFORMATION WAS PROVIDED REGARDING THE OTHER TWO PATIENTS' RESULTS. THE ERRONEOUS ALB AND CCRP PATIENT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY HOWEVER THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. NO ERROR MESSAGES WERE OBSERVED PRIOR TO DISCOVERY OF THE EVENT. THE CUSTOMER INDICATED THAT ASSAY QUALITY CONTROL (QC) RESULTS MET SPECIFICATIONS PRIOR TO THE EVENT. THE HEALTHCARE WORKER INTERFACING WITH THE MACHINE WAS WEARING PERSONAL PROTECTIVE EQUIPMENT WHICH INCLUDED A LABORATORY COAT, EYE PROTECTION AND GLOVES. THERE WAS NO EXPOSURE TO HEALTHCARE WORKER UNCOVERED WOUNDS OR MUCOUS MEMBRANES AND NO INJURY WAS REPORTED. NO PERSONNEL SOUGHT ANY MEDICAL ATTENTION IN ASSOCIATION WITH THIS EVENT. NO DEATH OR INJURY WAS ASSOCIATED WITH THIS EVENT. THERE WAS AN EXPOSURE PLAN IN PLACE AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM NEPHELOMETER, FOR CLINICAL USE NQD BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1