BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS B 123 <4> SYSTEM

    MDR report key: 3052169 · Received April 11, 2013

    Report

    Report Number
    1823260-2013-02202
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 4, 2013
    Report Date
    July 10, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K111188
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE DIFFERENCES OBSERVED BETWEEN THE B123 AND THE OTHER TWO ANALYZERS ARE DUE TO METHODOLOGY DIFFERENCES. THE B123 IS THE NEWEST OF THE BLOOD GAS ANALYZERS AND WAS DESIGNED BASED ON THE NEWEST TECHNICAL STANDARDS USING NIST ARE DOUMAS AS REFERENCE METHODS. MOST OF THE COMPETITOR ANALYZERS AS WELL AS THE B221 DO NOT USE THIS CALIBRATION MODEL. FOR PATIENT THREE, IT WAS NOTED THAT THE RESULTS FROM THE B123 WERE TOO HIGH COMPARED TO THE CALIBRATION. THIS INDICATES A SAMPLE RELATED ISSUE. THE INVESTIGATION SHOWED NO SIGNS OF A SENSOR OR ANALYZER RELATED PROBLEM. THERE WERE NO INDICATIONS OF AN INTERFERING SUBSTANCE. THE CALIBRATION AND QUALITY CONTROL DATA WERE WITHIN RANGE. IT WAS DETERMINED THE ANALYZER MET SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE BILIRUBIN RESULTS FOR FOUR PATIENTS ON THEIR COBAS B123 ANALYZER. THE CUSTOMER PROVIDED DATA FOR FOUR PATIENTS, THREE OF WHICH HAD DISCREPANT RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY. THE INITIAL RESULTS DID NOT MATCH THE CLINICAL PICTURES OF THE PATIENTS. THE MEASUREMENTS FROM THE B123 AND COBAS B221 ANALYZERS WERE PERFORMED WITH CAPILLARY BLOOD SAMPLES. THE MEASUREMENTS FROM THE INTEGRA 800 WERE PERFORMED ON VENOUS BLOOD SAMPLES. THE FIRST PATIENT'S INITIAL BILIRUBIN RESULT WAS 22.5 MG/DL. A SAMPLE WAS REPEATED ON A COBAS INTEGRA 800, SERIAL NUMBER (B)(4), AND THE RESULT WAS 15.45 MG/DL. ON (B)(6) 2013, THE SECOND PATIENT, A MALE BORN ON (B)(6), HAD A BILIRUBIN RESULT FROM THE B123 ANALYZER OF 20.6 MG/DL. THE SAMPLE WAS TESTED ON A COBAS B221 ANALYZER, SERIAL NUMBER (B)(4), AND THE RESULT WAS 15.2 MG/DL. A SAMPLE WAS THEN TESTED ON THE INTEGRA 800 AND THE RESULT WAS 13.65 MG/DL. ON (B)(6) 2013, THE THIRD PATIENT A FEMALE BORN ON (B)(6) WHO WEIGHED (B)(6), HAD AN INITIAL RESULT FROM THE B123 ANALYZER UNDER 3.0 MG/DL. THE SAMPLE WAS REPEATED ON THE B221 ANALYZER AND THE RESULT WAS BELOW THE MEASURING RANGE. THE SAMPLE WAS THEN REPEATED ON THE B123 ANALYZER AND THE RESULT WAS 14.5 MG/DL. THE SAMPLE WAS REPEATED ON THE B221 ANALYZER AND THE RESULT WAS BELOW THE MEASURING RANGE. ON (B)(6) 2013, THE SAMPLE WAS THEN REPEATED ON THE B123 ANALYZER AND THE RESULT WAS 14.7 MG/DL. THE SAMPLE WAS REPEATED ON THE B221 ANALYZER AND THE RESULT WAS BELOW THE MEASURING RANGE. A SAMPLE WAS TESTED ON THE INTEGRA 800 ANALYZER AND THE RESULT WAS 9.11 MG/DL. DUE TO THE INITIAL RESULTS, THE PATIENTS WERE GIVEN PHOTOTHERAPY. THE PATIENTS WERE NOT HARMED BY THIS EVENT. THE BILIRUBIN REAGENT LOT NUMBER WAS 21426561 AND THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156248 COBAS B 123 <4> SYSTEM BLOOD GAS ANALYZER CHL ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 003 DA