BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 3222266 · Received July 12, 2013

    Report

    Report Number
    1823260-2013-04211
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 25, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZV
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE DUE TO LACK OF RELEVANT INFORMATION. THE OBSERVATION OF THE FIELD SERVICE REPRESENTATIVE COULD NOT BE SEEN AS A TRUE ROOT CAUSE, AS NOT ALL ASSAYS SHOWED ISSUES. IT WAS NOTED THAT INCORRECT SAMPLE COLLECTION OR CONTAMINATION COULD BE SEEN AS A ROOT CAUSE. IT WAS ALSO NOTED THAT THE CENTRIFUGATION TIME WAS TOO SHORT AND AT TOO HIGH A SPEED. THE CUSTOMER INDICATED THAT AFTER PERFORMING THE GREEN RACK MAINTENANCE AND A NEW CALIBRATION AND QC, THEY HAD NO FURTHER ISSUES. IT WAS NOTED THAT THE GREEN RACK PROCEDURE MAY HAVE REMOVED POTENTIAL CONTAMINATION.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ION SELECTIVE ELECTRODE (ISE) POTASSIUM (K) ON THREE PATIENTS. ALL RESULTS ARE IN MMOL/L. PATIENT 1 HAD AN INITIAL K RESULT OF 5.57. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501 ANALYZER AND GENERATED A REPEAT RESULT OF 4.20. PATIENT 2 HAD AN INITIAL K RESULT OF 5.11. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501 ANALYZER AND GENERATED A REPEAT RESULT OF 3.66. PATIENT 3 HAD AN INITIAL K RESULT OF 5.05. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501 ANALYZER AND GENERATED A REPEAT RESULT OF 3.74. THE INITIAL RESULTS FOR ALL THREE PATIENTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DEEMED THE REPEAT RESULT TO BE THE CORRECT RESULT. THE CUSTOMER ISSUED CORRECTED REPORTS. THERE WAS NO ADVERSE EVENT. THE CUSTOMER WAS ASKED TO PROVIDE THE LOT NUMBER AND EXPIRATION DATE OF THE K ELECTRODE IN USE, BUT IT WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE (FSR) FOUND THE CARTRIDGE WAS NOT SEATED CORRECTLY. THE CUSTOMER INDICATED TO THE FSR THAT THEIR CARTRIDGES WERE NO SEATED CORRECTLY. THE CUSTOMER REINSTALLED THEM AND WAS OKAY. THE CUSTOMER PERFORMED QC WHICH WAS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321473 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER MZV ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1