BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1022492 · Received March 31, 2008

    Report

    Report Number
    1823260-2008-02884
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EIGHT PATIENT SAMPLES WITH DISCREPANT POTASSIUM RESULTS. PATIENT 1, INITIAL GAVE 3.2 MMOL/L, REPEAT GAVE 3.9 MMOL/L. INITIAL RESULTS WERE REPORTED. PATIENTS 1, 3, 4, 5 AND 6 RECEIVED TREATMENT BASED ON THE INCORRECT RESULTS. PATIENT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 2

    EIGHT PATIENT SAMPLES WITH DISCREPANT POTASSIUM RESULTS. PATIENT 2, INITIAL GAVE 2.9 MMOL/L, REPEAT GAVE 3.5 MMOL/L. INITIAL RESULTS WERE REPORTED. PATIENTS 1, 3, 4, 5 AND 6 RECEIVED TREATMENT BASED ON THE INCORRECT RESULTS. PATIENT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 3

    EIGHT PATIENT SAMPLES WITH DISCREPANT POTASSIUM RESULTS. PATIENT 3, INITIAL GAVE 3.2 MMOL/L, REPEAT GAVE 3.9 MMOL/L. INITIAL RESULT WERE REPORTED. PATIENTS 1, 3, 4, 5 AND 6 RECEIVED TREATMENT BASED ON THE INCORRECT RESULTS. PATIENT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 4

    EIGHT PATIENT SAMPLES WITH DISCREPANT POTASSIUM RESULTS. PATIENT 4, INITIAL GAVE 3.1 MMOL/L; REPEAT GAVE 3.9 MMOL/L. INITIAL RESULTS WERE REPORTED. PATIENTS 1,3, 4, 5 AND 6 RECEIVED TREATMENT BASED ON THE INCORRECT RESULTS. PATIENTS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 5

    EIGHT PATIENT SAMPLES WITH DISCREPANT POTASSIUM RESULTS. PATIENT 5, INITIAL GAVE 3.1 MMOL/L; REPEAT GAVE 3.7 MMOL/L. INITIAL RESULTS WERE REPORTED. PATIENTS 1, 3, 4, 5 AND 6 RECEIVED TREATMENT BASED ON THE INCORRECT RESULTS. PATIENTS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 6

    EIGHT PATIENT SAMPLES WITH DISCREPANT POTASSIUM RESULTS. PATIENT 6, INITIAL GAVE 3.0 MMOL/L; REPEAT GAVE 3.6 MMOL/L. INITIAL RESULTS WERE REPORTED. PATIENTS 1, 3, 4, 5 AND 6 RECEIVED TREATMENT BASED ON THE INCORRECT RESULTS. PATIENT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 7

    EIGHT PATIENT SAMPLES WITH DISCREPANT POTASSIUM RESULTS. PATIENT 7, INITIAL GAVE 3.2 MMOL/L; REPEAT GAVE 3.8 MMOL/L. INITIAL RESULTS WERE REPORTED. PATIENTS 1, 3, 4, 5 AND 6 RECEIVED TREATMENT BASED ON THE INCORRECT RESULTS. PATIENTS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 8

    EIGHT PATIENT SAMPLES WITH DISCREPANT POTASSIUM RESULTS. PATIENT 8, INITIAL GAVE 5.2 MMOL/L; REPEAT GAVE 6.0 MMOL/L. INITIAL RESULTS WERE REPORTED. PATIENTS 1, 3, 4, 5 AND 6 RECEIVED TREATMENT BASED ON THE INCORRECT RESULTS. PATIENT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER - CEM CEM ROCHE DIAGNOSTICS C501 69086201

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK
    2
    3 UNK
    4 UNK
    5 UNK
    6 UNK
    7 UNK
    8 UNK