BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS ISE MODULE (DOUBLE)

    MDR report key: 2980739 · Received February 27, 2013

    Report

    Report Number
    1823260-2013-01190
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 10, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE LATER CONFIRMED THAT THE FOREIGN MATERIAL FOUND ON THE PROBE WAS GEL FROM GEL SEPERATOR TUBES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY NOTICED THAT ION SELECTIVE ELECTRODE (ISE) SODIUM RESULTS WERE RUNNING HIGH WHEN THEY RAN DAILY COMPARISON TESTING WITH THIS ANALYZER AND THEIR OTHER COBAS 8000 SYSTEM. THEY RAN CALIBRATION AND QUALITY CONTROLS WITH THESE RECOVERING WITHIN RANGE. THEY THEN REPEATED COMPARISON TESTING AND RESULTS WERE STILL HIGH. THE CUSTOMER THEN REPEATED PATIENT SAMPLES. A TOTAL OF (B)(4) SAMPLES WERE QUESTIONED AND (B)(4) OF THESE WERE FOUND TO HAVE ERRONEOUS INITIAL RESULTS. ALL INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. SAMPLES WERE REPEATED ON COBAS 8000 CORE ANALYZER SERIAL NUMBER (B)(4) AND THESE REPEAT RESULTS WERE CONSIDERED TO BE CORRECT. SAMPLE ONE INITIALLY RESULTED AS 140 MMOL/L AND REPEATED AS 134.7 MMOL/L. A CORRECTED REPORT WAS ISSUED WITH A VALUE OF 135 MMOL/L. SAMPLE TWO INITIALLY RESULTED AS 150 MMOL/L AND REPEATED AS 142.9 MMOL/L. A CORRECTED REPORT WAS ISSUED WITH A VALUE OF 143 MMOL/L. SAMPLE THREE INITIALLY RESULTED AS 148 MMOL/L AND REPEATED AS 142.0 MMOL/L. A CORRECTED REPORT WAS ISSUED WITH A VALUE OF 142 MMOL/L. SAMPLE FOUR INITIALLY RESULTED AS 150 MMOL/L AND REPEATED AS 144.9 MMOL/L. SAMPLE FIVE INITIALLY RESULTED AS 147 MMOL/L AND REPEATED AS 140.2 MMOL/L. A CORRECTED REPORT WAS ISSUED WITH A VALUE OF 140 MMOL/L. SAMPLE SIX INITIALLY RESULTED AS 149 MMOL/L AND REPEATED AS 143.9 MMOL/L. SAMPLE SEVEN INITIALLY RESULTED AS 148 MMOL/L AND REPEATED AS 141.6 MMOL/L. A CORRECTED REPORT WAS ISSUED WITH A VALUE OF 142 MMOL/L. SAMPLE EIGHT INITIALLY RESULTED AS 148 MMOL/L AND REPEATED AS 141.2 MMOL/L. A CORRECTED REPORT WAS ISSUED WITH A VALUE OF 141 MMOL/L. SAMPLE NINE INITIALLY RESULTED AS 148 MMOL/L AND REPEATED AS 142.4 MMOL/L. SAMPLE TEN INITIALLY RESULTED AS 151 MMOL/L AND REPEATED AS 145.0 MMOL/L. SAMPLE ELEVEN INITIALLY RESULTED AS 148 MMOL/L AND REPEATED AS 141.6 MMOL/L. A CORRECTED REPORT WAS ISSUED WITH A VALUE OF 142 MMOL/L. SAMPLE TWELVE INITIALLY RESULTED AS 146 MMOL/L AND REPEATED AS 140.9 MMOL/L. SAMPLE THIRTEEN INITIALLY RESULTED AS 139 MMOL/L AND REPEATED AS 133.8 MMOL/L. SAMPLE FOURTEEN INITIALLY RESULTED AS 139 MMOL/L AND REPEATED AS 133.4 MMOL/L. SAMPLE FIFTEEN INITIALLY RESULTED AS 150 MMOL/L AND REPEATED AS 144.6 MMOL/L. THE PATIENTS WERE NOT ADVERSELY AFFECTED BY THE EVENT. THE ISE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THERE WAS FOREIGN MATERIAL ON THE ISE SAMPLE PROBE. HE REPLACED THE SAMPLE PROBE. HE PERFORMED AND ISE CHECK X100 AND THIS PASSED. THE CUSTOMER PERFORMED CALIBRATION AND QUALITY CONTROLS WITH RESULTS WITHIN THEIR SPECIFICATIONS. THE CUSTOMER RAN PATIENT COMPARISONS AND RESULTS WERE TO THEIR SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83935 COBAS 8000 COBAS ISE MODULE (DOUBLE) CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1