BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3122425 · Received May 21, 2013

    Report

    Report Number
    1823260-2013-03082
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 8, 2013
    Report Date
    July 12, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED DATA FOR TWO ADDITIONAL SAMPLES OUT OF THE "ABOUT 30" SAMPLES THEY HAD QUESTIONED. ALL RESULTS ARE IN UIU/ML, AND BOTH SAMPLES WERE RUN ON (B)(6) 2013. PATIENT 3 HAD AN INITIAL TSH RESULT OF 8.25, ACCOMPANIED BY A DATA FLAG. THE SAMPLE AUTO-REPEATED AND GENERATED A RESULT OF 7.54, ACCOMPANIED BY A DATA FLAG. NEITHER OF THESE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS THEN RUN ON COBAS 6000 E601 (E601) ANALYZER SERIAL NUMBER (B)(4) AND GENERATED A RESULT OF 12.64. THE SAMPLE WAS REPEATED A SECOND TIME ON C601 SERIAL NUMBER (B)(4) AND GENERATED A RESULT OF 12.69. THE CUSTOMER DEEMED THE RESULTS FROM ANALYZER SERIAL NUMBER (B)(4) TO BE CORRECT AND REPORTED THEM OUTSIDE OF THE LABORATORY. THERE WAS NO ADVERSE EVENT. PATIENT 4 HAD AN INITIAL TSH RESULT OF 9.79, ACCOMPANIED BY A DATA FLAG. THE SAMPLE AUTO-REPEATED AND GENERATED A RESULT OF 6.55. NEITHER OF THESE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS THEN RUN ON E601 SERIAL NUMBER (B)(4) AND GENERATED A REPEAT RESULT OF 10.08. THE SAMPLE WAS REPEATED A SECOND TIME ON C601 SERIAL NUMBER (B)(4) AND GENERATED A RESULT OF 10.22. THE CUSTOMER DEEMED THE RESULTS FROM E601 SERIAL NUMBER (B)(4) TO BE CORRECT AND REPORTED THEM OUTSIDE OF THE LABORATORY. THERE WAS NO ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. THE QC DATA FROM THE DATE OF THE EVENT WAS EVALUATED AND IT WAS NOTED THAT NOT ALL OF THE QC VALUES WERE WITHIN THEIR SPECIFIED RANGES. SINCE THE SAME REAGENTS WERE IN USE ON BOTH ANALYZERS, A GENERAL REAGENT ISSUE CAN BE EXCLUDED BECAUSE, THE CALIBRATION SIGNALS AND QC RESULTS ARE WITHIN ALL SPECIFICATIONS ON ANALYZER SERIAL NUMBER (B)(4). REVIEW OF THE PROVIDED CALIBRATION DATA INDICATED THAT THE CALIBRATIONS PRIOR TO THE EVENT ON THE ANALYZER WERE DIFFERENT THAN THE CALIBRATIONS ON ANALYZER SERIAL NUMBER (B)(4), WHICH WERE WITHIN EXPECTATIONS. THE CUSTOMER INDICATED THEY ARE NO LONGER HAVING ISSUES WITH THE RESULTS DIFFERING BETWEEN THE TWO MEASURING CELLS.

    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 ON THYROTROPIN (TSH) FOR "ABOUT 30" PATIENTS. OF THOSE, THE CUSTOMER WAS ABLE TO PROVIDE DATA FOR TWO PATIENTS. ALL RESULTS ARE IN UIU/ML. THE CUSTOMER WAS HAVING DIFFICULTY WITH QUALITY CONTROLS VARYING BETWEEN THE TWO MEASURING CELLS ON (B)(6) 2013. PATIENT 1 HAD AN INITIAL RESULT OF 1.57. THIS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON COBAS E601 MODULE SERIAL NUMBER (B)(4) AND GENERATED A REPEAT RESULT OF 2.51. THE REPEAT RESULT WAS DEEMED TO BE THE CORRECT RESULT BY THE CUSTOMER AND WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ADVERSE EVENT. PATIENT 2 HAD AN INITIAL RESULT OF 4.13. THIS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON COBAS E601 MODULE SERIAL NUMBER (B)(4) AND GENERATED A REPEAT RESULT OF 6.46. THE REPEAT RESULT WAS DEEMED TO BE THE CORRECT RESULT BY THE CUSTOMER AND WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ADVERSE EVENT. THE LOT OF TSH REAGENT IN USE WAS 17122601, WITH AN EXPIRATION DATE OF 09/30/2013. THE FIELD SERVICE REPRESENTATIVE CHECKED THE FLUIDICS AND PERFORMED MECHANISM CHECKS. HE ALSO DID PERFORMANCE TESTING, WHICH WAS WITHIN RANGE. THE CUSTOMER PERFORMED CALIBRATION AND QC, WHICH WAS WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224466 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JLW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1