BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 3031199 · Received April 2, 2013

    Report

    Report Number
    1823260-2013-01988
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    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

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. IT WAS NOTED THE CUSTOMER WAS NOT FOLLOWING THE TUBE MANUFACTURER'S RECOMMENDATIONS FOR CENTRIFUGATION TIME AND SPEED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER DISCOVERED QUESTIONABLE LOW ION SELECTIVE ELECTRODE (ISE) SODIUM RESULTS FOR 30 PATIENT SAMPLES WHEN THE RESULTS FOR TWO PATIENT SAMPLES WERE QUESTIONED BY A PHYSICIAN. THE SAMPLES WERE EITHER REPEATED ON COBAS C501 ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE RESULTS FOR 14 PATIENT SAMPLES WERE DISCREPANT. ALL RESULTS ARE IN MMOL/L. PATIENT SAMPLE 1 INITIAL RESULT WAS 129 AND THE REPEAT RESULT WAS 135. PATIENT SAMPLE 2 ((B)(6), FEMALE) INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 140. PATIENT SAMPLE 3 ((B)(6), MALE) INITIAL RESULT WAS 125 AND THE REPEAT RESULT WAS 132. PATIENT SAMPLE 4 (B)(6), FEMALE) INITIAL RESULT WAS 125 AND THE REPEAT RESULT WAS 131. PATIENT SAMPLE 5 ((B)(6), FEMALE) INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 137. PATIENT SAMPLE 6 ((B)(6), FEMALE) INITIAL RESULT WAS 128 AND THE REPEAT RESULT WAS 134. PATIENT SAMPLE 7 ((B)(6), FEMALE) INITIAL RESULT WAS 125 AND THE REPEAT RESULT WAS 132. PATIENT SAMPLE 8 ((B)(6), MALE) INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 138. PATIENT SAMPLE 9 ((B)(6), MALE) INITIAL RESULT WAS 127 AND THE REPEAT RESULT WAS 133. PATIENT SAMPLE 10 ((B)(6), FEMALE) INITIAL RESULT WAS 124 AND THE REPEAT RESULT WAS 130. PATIENT SAMPLE 11 ((B)(6), FEMALE) INITIAL RESULT WAS 125 AND THE REPEAT RESULT WAS 131. PATIENT SAMPLE 12 ((B)(6), FEMALE) INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 137. PATIENT SAMPLE 13 ((B)(6), FEMALE) INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 138. PATIENT SAMPLE 14 ((B)(6), MALE) INITIAL RESULT WAS 127 AND THE REPEAT RESULT WAS 133. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE SODIUM ELECTRODE LOT NUMBER WAS Q75. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE NOTED THE CUSTOMER HAD REPLACED THE ISE REAGENTS, RUN CALIBRATION, AND THAT THE QC RESULTS WERE BACK UP TO A NORMAL VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134589 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR