BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2822983 · Received November 7, 2012

    Report

    Report Number
    1823260-2012-05653
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE AS THE DATA AND OTHER REQUIRED INFORMATION WAS NOT AVAILABLE FROM THE CUSTOMER. THE QUALITY CONTROL DATA WAS WITHIN THE SPECIFIED RANGES. THERE WAS NO INDICATION OF ANY REAGENT OR SYSTEM ISSUE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE UNIT OF MEASURE WAS NG/DL.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE HIGH FREE THYROXINE (FT4) RESULTS, FOR 14 PATIENT SAMPLES. THE SAMPLES WERE REPEATED ON (B)(6) 2012. OF THE DATA PROVIDED, THE RESULTS FOR 13 OF THE PATIENT SAMPLES WERE DISCREPANT. NO UNITS OF MEASURE WERE PROVIDED. CLARIFICATION WAS REQUESTED. PATIENT SAMPLE 1: INITIAL RESULT WAS 1.98 AND THE REPEAT RESULT WAS 1.49. PATIENT SAMPLE 2: INITIAL RESULT WAS 1.81 AND THE REPEAT RESULT WAS 1.31. PATIENT SAMPLE 3: INITIAL RESULT WAS 2.18 AND THE REPEAT RESULT WAS 1.64. PATIENT SAMPLE 4: INITIAL RESULT WAS 2.07 AND THE REPEAT RESULT WAS 1.44. PATIENT SAMPLE 5: INITIAL RESULT WAS 2.04 AND THE REPEAT RESULT WAS 1.48. PATIENT SAMPLE 6: INITIAL RESULT WAS 1.86 AND THE REPEAT RESULT WAS 1.34. PATIENT SAMPLE 7: INITIAL RESULT WAS 2.05 AND THE REPEAT RESULT WAS 1.53. PATIENT SAMPLE 8: INITIAL RESULT WAS 1.96 AND THE REPEAT RESULT WAS 1.41. PATIENT SAMPLE 9: INITIAL RESULT WAS 1.64 AND THE REPEAT RESULT WAS 1.21. PATIENT SAMPLE 10: INITIAL RESULT WAS 1.92 AND THE REPEAT RESULT WAS 1.33. PATIENT SAMPLE 11: INITIAL RESULT WAS 2.10 AND THE REPEAT RESULT WAS 1.49. PATIENT SAMPLE 12: INITIAL RESULT WAS 2.00 AND THE REPEAT RESULT WAS 1.40 PATIENT SAMPLE 13: INITIAL RESULT WAS 2.12 AND THE REPEAT RESULT WAS 1.51. NONE OF THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NONE OF THE PATIENTS WERE HARMED OR ADVERSELY AFFECTED. THE FT4 REAGENT LOT NUMBER WAS 168454. THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1