BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3070749 · Received April 22, 2013

    Report

    Report Number
    1823260-2013-02439
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 10, 2013
    Report Date
    October 1, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DATA WAS PROVIDED FOR TWO ADDITIONAL PATIENT SAMPLES WITH QUESTIONABLE HEMOGLOBIN A1C RESULTS ON (B)(6) 2013. PATIENT SAMPLE 1 INITIAL RESULT WAS 9.9% AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED AND THE RESULT WAS 7.5% AND WAS SENT AS A CORRECTED REPORT. FOR TROUBLESHOOTING PURPOSES, THE SAMPLE WAS REPEATED ON (B)(6) 2013 AND THE RESULT WAS 7.4%. PATIENT SAMPLE 2 INITIAL RESULT WAS 10.5% AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED AND THE RESULT WAS 7.3% AND WAS SENT AS A CORRECTED REPORT. FOR TROUBLESHOOTING PURPOSES, THE SAMPLE WAS REPEATED ON (B)(6) 2013 AND THE RESULT WAS 7.0%. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE PATIENTS WERE NOT ADVERSELY AFFECTED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE DUE TO THE LACK OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER. A GENERAL REAGENT ISSUE WITH HEMOGLOBIN A1C WAS NOT SUSPECTED AS THE PROVIDED QC DATA WERE ACCEPTABLE.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR BICARBONATE, ION SELECTIVE ELECTRODE (ISE)-SODIUM AND HEMOGLOBIN A1C FOR THREE SEPARATE PATIENT SAMPLES. OF THE DATA PROVIDED, ONLY THE RESULTS FOR SODIUM AND HEMOGLOBIN A1C WERE DISCREPANT. THE INITIAL SODIUM RESULT WAS 163 MMOL/L AND THE REPEAT RESULT WAS 142 MMOL/L. THE INITIAL HEMOGLOBIN A1C RESULT WAS 12% AND THE REPEAT RESULT WAS 7.2%. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND WERE QUESTIONED BY THE DOCTOR. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE HEMOGLOBIN A1C REAGENT LOT NUMBER WAS 66926901 WITH AN EXPIRATION DATE OF 11/30/2013. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE. HE FLUSHED THE RINSE MECHANISM, FOUND THE GEAR PUMP PRESSURE WAS LOW AND ADJUSTED IT TO PROPER PRESSURE, CHECKED OUTPUT OF SAMPLE SYRINGE, REPLACED SAMPLE PROBE AND PERFORMED ADJUSTMENTS, CHECKED CUVETTES AND ADJUSTED RINSE LEVELS TO WASH PROPERLY. THE CUSTOMER PERFORMED CALIBRATION AND QC WITH ALL RESULTS WITHIN SPECIFIED RANGES. THE FIELD SERVICE REPRESENTATIVE RAN PRECISION TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172917 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1