BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS B 221<6>=ROCHE OMNI S6 SYSTEM

    MDR report key: 3745842 · Received April 11, 2014

    Report

    Report Number
    1823260-2014-02591
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 18, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJC
    PMA / PMN Number
    K945915
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE CONTAMINATION FOUND ON THE CUVETTES WAS PROBABLY DUE TO RESIDUAL BLOOD OR MICRO CLOTS THAT COULD NOT BE WASHED OUT. DURING THE INVESTIGATION, THERE WAS INFORMATION SUGGESTING THE QUALITY CONTROL CONCEPT WAS NOT PROPERLY APPLIED BY THE CUSTOMER. TWO CONTAMINATED CUVETTES WERE RETURNED BY THE CUSTOMER FOR INVESTIGATION AND PRODUCED QUALITY CONTROL MEASUREMENT ALARMS WHEN TESTED. THE CUSTOMER'S QUALITY CONTROL VERIFICATION SHOULD HAVE WARNED THE CUSTOMER ABOUT THE STATE OF THE SYSTEM, IF IT WAS PROPERLY APPLIED. PROPERLY APPLYING THE QUALITY CONTROL CONCEPTS ALLOW THE CUSTOMER TO DETECT THESE CONTAMINATIONS EARLIER AND ADJUST THEIR CLEANING PROTOCOLS. NO HINTS OF AN INSTRUMENT BASED ERROR COULD BE OBSERVED. NO GENERAL CUVETTE PROBLEMS HAVE BEEN REPORTED. THE INSTRUMENT HAS BEEN REMOVED FROM THE LABORATORY.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLY LOW TOTAL HEMOGLOBIN RESULTS ON THEIR B221 ANALYZER. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT WITH A DISCREPANT RESULT. THE PATIENT'S INITIAL TOTAL HEMOGLOBIN RESULT WAS 8.7 G/DL AND IT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER STATED THAT IN THE "PEDIATRIC INTENSIVE ROOM", THE DOCTORS COMPLAINED THAT THE VALUE OF TOTAL HEMOGLOBIN WAS VERY LOW AND SHOULD BE AROUND 13 G/DL. THE SAMPLE WAS REPEATED WITH A SYSMEX HEMATOLOGY AUTOMATED ANALYZER, MODEL XE2100. THE REPEAT RESULT WAS 12 G/DL. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE TOTAL HEMOGLOBIN CARTRIDGE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. DURING THE EVALUATION OF THE ANALYZER, IT WAS FOUND THAT THERE WAS A LAYER OF BROWN COLOR ON THE WALLS OF THE CUVETTE. THE CLEANING PROCEDURE WAS DONE, BUT THE LOW RESULTS WERE STILL PRESENT. AN AUTOMATIC CLEANING EVERY 20 SAMPLES WAS INITIATED, BUT THE PROBLEM PERSISTED. THE CUVETTE WAS REPLACED AND CALIBRATION WAS PERFORMED. AFTER REPLACING THE CUVETTE, THE HEMOGLOBIN RESULTS CAME BACK TO THE NORMAL RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224701 COBAS B 221<6>=ROCHE OMNI S6 SYSTEM BLOOD GAS ANALYZER JJC ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1