BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3222525 · Received July 12, 2013

    Report

    Report Number
    1823260-2013-04220
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 25, 2013
    Report Date
    August 13, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE DUE TO LACK OF INFORMATION. A REAGENT RELATED ISSUE COULD BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. RESULTS-DEVICE SUBASSEMBLY- MEASURING CELL. FOR MEDWATCH ON ERRONEOUS FT4 AND TOTAL PROSTATE SPECIFIC ANTIGEN RESULTS FROM (B)(6) 2013, REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR FREE THYROXINE (FT4) ON THREE SAMPLES, TOTAL (FREE + COMPLEXED) PROSTATE SPECIFIC ANTIGEN (PSA) ON TWO SAMPLES AND FT4 AND PSA ON ONE SAMPLE. OF THOSE SIX SAMPLES, IT WAS DETERMINED THAT TWO SAMPLES HAD ERRONEOUS FT4 RESULTS. ONE OF THOSE SAMPLES HAD ERRONEOUS RESULTS REPORTED OUTSIDE OF THE LABORATORY. FT4 UNITS ARE NG/DL. THE CUSTOMER HAD NOTED THAT THE ISSUE FROM (B)(6) 2013 WAS OCCURRING AGAIN ON (B)(6) 2013. PATIENT 1 HAD AN INITIAL FT4 RESULT OF 7.77, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AND GENERATED A REPEAT RESULT OF 6.19. THE CUSTOMER QUESTIONED THE REPEAT RESULT AND SENT THE SAMPLE TO ANOTHER LABORATORY FOR TESTING. THE OTHER LABORATORY TESTED THE SAMPLE ON A COBAS 6000, AND GENERATED A RESULT OF 1.00. THE CUSTOMER DEEMED THE REPEAT RESULTS TO BE THE CORRECT RESULTS. THERE WAS NO ADVERSE EVENT. PATIENT 2 HAD AN INITIAL FT4 RESULT OF 7.39, WHICH WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER QUESTIONED THE RESULT AND SENT THE SAMPLE TO ANOTHER LABORATORY FOR TESTING. THE OTHER LABORATORY TESTED THE SAMPLE ON A COBAS 6000 AND GENERATED A RESULT OF 70.94. THE CUSTOMER DEEMED THE RESULT FROM THE OTHER LABORATORY TO BE CORRECT. THERE WAS NO ADVERSE EVENT. THE LOT OF FT4 REAGENT IN USE WAS 17207601, WITH AN EXPIRATION DATE OF 05/31/2014. THE FIELD SERVICE REPRESENTATIVE VISITED THE CUSTOMER BETWEEN (B)(4) 2013. THE FIRST VISIT, HE COULD NOT DETERMINE A CAUSE FOR THE ISSUE. HE CHECKED THE FUNCTIONALITY OF THE INSTRUMENT. HE COULD NOT DETERMINE A CAUSE ON THE SECOND OR THIRD VISIT FOR THE ISSUE, AND ORDERED PARTS FOR REPLACEMENT. THE FOURTH VISIT, HE REPLACED THE MEASURING CELLS. HE DID PERFORMANCE TESTING, WHICH PASSED. THE CUSTOMER RAN CALIBRATION AND QC, WHICH MET THE LABORATORY'S SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322877 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1