BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3632472 · Received February 18, 2014

    Report

    Report Number
    1823260-2014-01066
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 29, 2014
    Report Date
    February 26, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE INTERNAL STANDARD WAS PROBABLY REPLACED DURING THE TIME FRAME OF (B)(6) 2014. THE CALIBRATION INFORMATION ALSO INDICATED THERE WAS A PROBLEM WITH THE HANDLING OF THE STANDARDS/REAGENTS. IT WAS ALSO NOTED THAT PRE- ANALYTICAL FACTORS MAY HAVE CONTRIBUTED TO THE ERRONEOUS RESULTS, BUT THIS COULD NOT BE CONFIRMED AS THE REQUESTED INFORMATION COULD NOT BE PROVIDED. THE ITEMS FOUND BY THE FIELD SERVICE REPRESENTATIVE DO NOT SEEM TO BE THE DIRECT ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ION SELECTIVE ELECTRODE (ISE) RESULTS ON FIVE ISE SODIUM (NA) SAMPLES AND TWO ISE CHLORIDE (CL) SAMPLES. IT WAS DETERMINED THAT THE FIVE ERRONEOUS NA RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER INDICATED THEY HAD A SIMILAR PROBLEM ON (B)(6) 2014. THE CUSTOMER THOUGHT THEY HAD RESOLVED THE ISSUE THE EVENING OF (B)(6) 2014, BUT THE CUSTOMER WAS STILL HAVING ISSUES THE MORNING OF (B)(6) 2014. THE FOLLOWING RESULTS ARE FOR NA AND ARE IN THE FORM OF INITIAL/ REPEAT AND ARE IN MMOL/L. PATIENT 1: 134/ 143, PATIENT 2: 128/ 140, PATIENT 3: 125/ 139, PATIENT 4: 131/ 141, PATIENT 5: 125/ 136. THE CUSTOMER INDICATED THE INITIAL RESULTS HAD BEEN REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED AND THE CUSTOMER DEEMED THE REPEAT RESULTS TO BE THE CORRECT RESULTS. THE CUSTOMER INDICATED THAT ALL RESULTS WERE CORRECTED AND THAT THERE WAS NO ADVERSE EVENT. THE LOT NUMBER OF THE NA ELECTRODE IN USE WAS X95, WITH AN EXPIRATION DATE OF 09/30/2014. THE FIELD SERVICE REPRESENTATIVE FOUND THAT THE INTERNAL STANDARD BATH WAS NOT EMPTYING COMPLETELY. HE ALSO FOUND THAT THE TUBING FROM TWO VALVES TO THE VACUUM CONTAINER WAS DISCONNECTED AT THE VACUUM CONTAINER. HE RESIZED AND ATTACHED THE TUBING. HE ALSO REPLACED THE SIPPER NOZZLE AND SAMPLE PROBE. CALIBRATIONS AND CONTROLS WERE WITHIN THE CUSTOMER'S SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103188 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1