BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2676309 · Received July 31, 2012

    Report

    Report Number
    1823260-2012-03914
    Event Type
    Malfunction
    Date Received
    July 31, 2012
    Date of Event
    July 24, 2012
    Report Date
    July 31, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGA
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR SEVENTEEN PATIENT SAMPLES TESTED FOR GLUCOSE HK (GLUCOSE), ION SELECTIVE ELECTRODE (ISE) SODIUM, AND ISE POTASSIUM. ALL INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT AND CORRECTED REPORTS WERE ISSUED FOR THE REPEAT RESULTS. PATIENT SAMPLE ONE INITIALLY RESULTED AS 132 MEQ/L FOR SODIUM. THE SAMPLE REPEATED AS 142 MEQ/L FOR SODIUM. PATIENT SAMPLE TWO FROM A (B)(6) MALE BORN ON (B)(6) 1941, INITIALLY RESULTED AS 128 MEQ/L FOR SODIUM AND 3.9 MEQ/L FOR POTASSIUM. THE SAMPLE REPEATED AS 142 MEQ/L FOR SODIUM AND 4.7 MEQ/L FOR POTASSIUM. PATIENT SAMPLE THREE FROM A (B)(6) MALE BORN ON (B)(6) 1938, INITIALLY RESULTED AS 133 MEQ/L FOR SODIUM. THE SAMPLE REPEATED AS 141 MEQ/L FOR SODIUM. PATIENT SAMPLE FOUR FROM A (B)(6) FEMALE BORN ON (B)(6) 1943, INITIALLY RESULTED AS 130 MEQ/L FOR SODIUM AND 3.4 MEQ/L FOR POTASSIUM. THE SAMPLE REPEATED AS 141 MEQ/L FOR SODIUM AND 4.0 MEQ/L FOR POTASSIUM. PATIENT SAMPLE FIVE FROM A (B)(6) FEMALE BORN ON (B)(6) 1950, INITIALLY RESULTED AS 133 MEQ/L FOR SODIUM. THE SAMPLE REPEATED AS 141 MEQ/L FOR SODIUM. PATIENT SAMPLE SIX FROM A (B)(6) MALE BORN ON (B)(6) 1934, INITIALLY RESULTED AS 131 MEQ/L FOR SODIUM. THE SAMPLE REPEATED AS 138 MEQ/L FOR SODIUM. PATIENT SAMPLE SEVEN FROM A (B)(6) FEMALE BORN ON (B)(6) 1930, INITIALLY RESULTED AS 129 MEQ/L FOR SODIUM. THE SAMPLE REPEATED AS 137 MEQ/L FOR SODIUM. PATIENT SAMPLE EIGHT FROM A (B)(6) MALE BORN ON (B)(6) 1941, INITIALLY RESULTED AS 131 MEQ/L FOR SODIUM AND 4.8 MEQ/L FOR POTASSIUM. THE SAMPLE REPEATED AS 138 MEQ/L FOR SODIUM AND 5.3 MEQ/L ACCOMPANIED BY A DATA FLAG FOR POTASSIUM. PATIENT SAMPLE NINE FROM A (B)(6) MALE BORN ON (B)(6) 1947, INITIALLY RESULTED AS 132 MEQ/L FOR SODIUM AND 3.6 MEQ/L FOR POTASSIUM. THE SAMPLE REPEATED AS 140 MEQ/L FOR SODIUM AND 4.1 MEQ/L FOR POTASSIUM. PATIENT SAMPLE TEN FROM A (B)(6) FEMALE BORN ON (B)(6) 1934, INITIALLY RESULTED AS 136 MEQ/L FOR SODIUM. THE SAMPLE REPEATED AS 144 MEQ/L FOR SODIUM. PATIENT SAMPLE ELEVEN FROM A (B)(6) FEMALE BORN ON (B)(6) 1991, INITIALLY RESULTED AS 130 MEQ/L FOR SODIUM AND 3.2 MEQ/L FOR POTASSIUM. THE SAMPLE REPEATED AS 140 MEQ/L FOR SODIUM AND 4.0 MEQ/L FOR POTASSIUM. PATIENT SAMPLE TWELVE FROM A (B)(6) MALE BORN ON (B)(6) 1944, INITIALLY RESULTED AS 131 MEQ/L FOR SODIUM. THE SAMPLE REPEATED AS 141 MEQ/L FOR SODIUM. PATIENT SAMPLE THIRTEEN FROM A (B)(6) MALE BORN ON (B)(6) 1933, INITIALLY RESULTED AS 130 MEQ/L FOR SODIUM AND 4.0 MEQ/L FOR POTASSIUM. THE SAMPLE REPEATED AS 138 MEQ/L FOR SODIUM AND 4.8 MEQ/L FOR POTASSIUM. PATIENT SAMPLE FOURTEEN FROM A (B)(6) MALE BORN ON (B)(6) 1944, INITIALLY RESULTED AS 134 MEQ/L FOR SODIUM. THE SAMPLE REPEATED AS 144 MEQ/L FOR SODIUM. PATIENT SAMPLE FIFTEEN FROM A (B)(6) FEMALE BORN ON (B)(6) 1952, INITIALLY RESULTED AS 134 MEQ/L FOR SODIUM. THE SAMPLE REPEATED AS 143 MEQ/L FOR SODIUM. PATIENT SAMPLE SIXTEEN FROM A (B)(6) FEMALE BORN ON (B)(6) 1968, INITIALLY RESULTED AS 130 MEQ/L FOR SODIUM. THE SAMPLE REPEATED AS 139 MEQ/L FOR SODIUM. PATIENT SAMPLE SEVENTEEN FROM A (B)(6) MALE BORN ON (B)(6) 1982, INITIALLY RESULTED AS 45 MG/DL ACCOMPANIED BY A DATA FLAG FOR GLUCOSE. THE SAMPLE REPEATED AS 64 MG/DL ACCOMPANIED BY A DATA FLAG FOR GLUCOSE. THE PATIENTS WERE NOT ADVERSELY AFFECTED BY THE EVENT. THE SODIUM ELECTRODE LOT NUMBER WAS P11 WITH AN EXPIRATION DATE OF 02/28/2013. THE POTASSIUM ELECTRODE LOT NUMBER WAS X25 WITH AN EXPIRATION DATE OF 02/28/2013. THE GLUCOSE REAGENT LOT NUMBER WAS 65676601 WITH AN EXPIRATION DATE OF 04/30/2013. THE CUSTOMER NOTICED THAT THE RINSE MECHANISM WAS DRIPPING AND OVERFILLING THE REACTION CELLS. THE FIELD SERVICE REPRESENTATIVE FOUND A LEAKY RINSE MECHANISM. HE REPLACED THE VACUUM PUMP DIAPHRAGM. CALIBRATION AND QUALITY CONTROL PERFORMED BY THE CUSTOMER PASSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR