BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 2864455 · Received December 10, 2012

    Report

    Report Number
    1823260-2012-06209
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZV
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED AS IT WAS NOT POSSIBLE TO PERFORM A THOROUGH INVESTIGATION WITH THE INFORMATION PROVIDED. PRECISION AND QUALITY CONTROL RESULTS ARE GOOD OVERALL. A SYSTEMATIC ISSUE CAN BE EXCLUDED SINCE ONLY ONE SAMPLE WAS AFFECTED. AN INSTRUMENT MALFUNCTION COULD NOT BE DETECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR ION SELECTIVE ELECTRODE (ISE) POTASSIUM. THE CUSTOMER STATED THAT FOR SEVERAL MONTHS, THEY HAVE BEEN HAVING STRUGGLES WITH ISE POTASSIUM CALIBRATION, QUALITY CONTROL AND PATIENT SAMPLES GENERATING VARIOUS ALARMS. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING PREVIOUS PATIENT SAMPLE RECOVERY. THE SAMPLE INITIALLY RESULTED AS 6.4 MMOL/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED AND RESULTED AS 6.7 MMOL/L ACCOMPANIED BY A DATA FLAG. THE RESULTS DID NOT FIT THE CLINICAL PICTURE OF THE PATIENT, SO THE SAMPLE WAS REPEATED AGAIN. THE SECOND REPEAT RESULT WAS 4.7 MMOL/L AND THIS VALUE WAS BELIEVED TO BE THE CORRECT RESULT. A CORRECTED REPORT WAS ISSUED FOR THE 4.7 MMOL/L. THE SAMPLE WAS REPEATED A THIRD AND FOURTH TIME, RESULTING AS 6.0 MMOL/L ACCOMPANIED BY A DATA FLAG AND 6.2 MMOL/L ACCOMPANIED BY A DATA FLAG RESPECTIVELY. THE CUSTOMER STATES THAT ONE OF THE ERRONEOUS VALUES WAS REPORTED OUTSIDE OF THE LABORATORY, BUT IT IS NOT KNOWN WHICH OF THESE WAS REPORTED. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE ISE POTASSIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED BY THE CUSTOMER. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE ISSUE WAS CAUSED BY THE ISE WASH TIME. HE ADJUSTED THE ISE WASH TIME AND COMMUNICATED TO THE CUSTOMER TO ORDER A NEW POTASSIUM ELECTRODE AS THEIRS WAS AT 90% OF LIFE EXPECTANCY. THE CUSTOMER CALIBRATION AND QUALITY CONTROL WAS PASSING WITHIN THEIR SPECIFICATIONS. THE CUSTOMER PRECISION IS PASSING WITHIN THEIR SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER MZV ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1