BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3182247 · Received June 21, 2013

    Report

    Report Number
    1823260-2013-03758
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 4, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    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

    BASED ON THE CALIBRATION INFORMATION PROVIDED, IT CAN BE SEEN THAT ONE OF THE STANDARDS USED FOR THE CALIBRATION WAS HIGHER CONCENTRATED. THE CUSTOMER MAY HAVE USED A HIGH STANDARD THAT HAD BEEN OPENED FOR TOO LONG. THE EFFECT IS SEEN IN THE COMPLAINED LOW SAMPLE RESULTS. THE ISSUE WAS RESOLVED ON SUBSEQUENT CALIBRATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR A TOTAL OF 50 PATIENT SAMPLES TESTED FOR ION SELECTIVE ELECTRODE (ISE) SODIUM. THE SAMPLES WERE INITIALLY RUN BETWEEN (B)(6) 2013. THE CUSTOMER NOTED THAT THE CALIBRATION FOR SODIUM AND CHLORIDE HAD COMPENSATED VALUES WHICH WERE NOT ACCEPTABLE ACCORDING TO THEIR LABORATORY PROCEDURES. QUALITY CONTROLS SHIFTED LOW, BUT WERE NOT OUTSIDE OF RANGE. PATIENT VALUES ALSO WENT LOWER. OF THE FIFTY QUESTIONED PATIENT SAMPLES, THE CUSTOMER PROVIDED EXAMPLES FOR FIVE PATIENT SAMPLES WHICH HAD ERRONEOUS RESULTS. ALL INITIAL SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THEY WERE QUESTIONED BY THE NURSE MANAGER. SAMPLES WERE REPEATED ON AN INTEGRA 400 ANALYZER (SERIAL (B)(4). REPEAT VALUES WERE BELIEVED TO BE CORRECT AND CORRECTED REPORTS WERE ISSUED FOR THESE SAMPLES. SAMPLE ONE INITIALLY RESULTED AS 131 MMOL/L AND REPEATED AS 139 MMOL/L. SAMPLE TWO, FROM A MALE BORN ON (B)(6) 1947, INITIALLY RESULTED AS 127 MMOL/L AND REPEATED AS 136 MMOL/L. SAMPLE THREE, FROM A FEMALE BORN ON (B)(6)1981, INITIALLY RESULTED AS 130 MMOL/L AND REPEATED AS 138 MMOL/L. SAMPLE FOUR, FROM A FEMALE BORN ON (B)(6)1953, INITIALLY RESULTED AS 134 MMOL/L AND REPEATED AS 141 MMOL/L. SAMPLE FIVE, FROM A MALE BORN ON (B)(6) 1947, INITIALLY RESULTED AS 123 MMOL/L AND REPEATED AS 130 MMOL/L. THE PATIENTS WERE NOT ADVERSELY AFFECTED BY THE EVENT. THE LOT NUMBER AND EXPIRATION DATE OF THE SODIUM ELECTRODE WERE NOT PROVIDED. ON (B)(6) 2013, THE CUSTOMER REPLACED ALL ELECTRODES, ISE REAGENTS, PINCH VALVE, AND SIPPER TUBING. AFTER DOING THIS, THE CUSTOMER PRIMED THE ANALYZER, RAN THE GREEN CLEANING RACK, AND PERFORMED AN ISE CHECK. THE CUSTOMER THEN CALIBRATED AND RAN QUALITY CONTROLS SUCCESSFULLY. ON THE EVENING OF (B)(6) 2013, A TECHNOLOGIST CALIBRATED AND RAN QUALITY CONTROLS FOR THE ISE TESTS AND THESE WERE NOT ACCEPTABLE. CALIBRATION AND CONTROLS WERE RUN AGAIN AND THESE ALSO WERE NOT ACCEPTABLE. THE CUSTOMER THEN RAN THE GREEN CLEANING RACK AND PERFORMED AND ISE CHECK. AFTER DOING THIS, THE CUSTOMER REPEATED CALIBRATION AND QUALITY CONTROLS SUCCESSFULLY. CALIBRATION AND CONTROLS WERE RUN AGAIN ON THE MORNING OF (B)(6) 2013 AND THESE WERE ACCEPTABLE. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE CHECKED THE ISE FLUIDICS AND STATED THAT THE CUSTOMER REPLACED ALL ELECTRODES AND REAGENTS PRIOR TO HIS ARRIVAL. HE PERFORMED A PRECISION STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283836 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 081 YR