BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2483774 · Received March 8, 2012

    Report

    Report Number
    1823260-2012-01309
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    December 21, 2011
    Report Date
    March 29, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LGD
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE SAME PATIENT SAMPLE WAS USED FOR TESTING ON THE COBAS, CENTUR, ABBOTT ARCHITECT, BIOMERIEUX VIDAS, FUMOUZE, WESTERN BLOT AND DYE TEST FOR THE SAMPLE FROM (B)(6) 2011 AND (B)(6) 2012. A SAMPLE FROM PATIENT WAS RETURNED FOR INVESTIGATION. THE SAMPLE WERE FOUND TO BE CORRECTLY POSITIVE/REACTIVE WITH THE ELECSYS TOXO IGG ASSAY. THESE RESULTS WERE CONFIRMED DURING INVESTIGATION USING A VALIDATED NEUTRALIZATION ASSAY.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE IGG ANTIBODIES TO TOXOPLASMA GONDII (TOXO) RESULTS ON THEIR E601 ANALYZER SINCE (B)(6) 2011. THE CUSTOMER PROVIDED DATA FOR TWO PATIENTS, ONE OF WHICH HAD DISCREPANT RESULTS REPORTED OUTSIDE THE LABORATORY. UNITS OF MEASURE WERE NOT PROVIDED. THE PATIENT'S INITIAL TOXO RESULT WAS 66. THE SAMPLE WAS REPEATED USING A WESTERN BLOT TEST AND THE RESULT WAS NEGATIVE. THE SAMPLE WAS REPEATED USING A DYE TEST AND THE RESULT WAS 1 NEGATIVE. THE PATIENT HAD A TOXO RESULT FROM AN ARCHITECT ANALYZER OF 0.8. THE PATIENT HAD A TOXO RESULT FROM A BIOMERIEUX ISAGA OF 0. THE PATIENT HAD A TOXO RESULT FROM A VIDAS ANALYZER OF 1 NEG. THE PATIENT HAD A TOXO RESULT FROM A CENTAUR XP ANALYZER OF 4. THE PATIENT HAD A TOXO RESULT FROM A HEMAGGLUTINATION TEST ON A (B)(4) DIAGNOSTICS ANALYZER WAS NEG. IT IS UNCLEAR IF THE RESULTS FROM THE ARCHITECT, BIOMERIEUX, VIDAS, CENTAUR, OR (B)(4) ANALYZERS CAME FROM THE SAME SAMPLE AS THE E601. CLARIFICATION HAS BEEN ASKED FOR. ON (B)(6) 2012, THE PATIENT'S INITIAL TOXO RESULT WAS 69. THE SAMPLE WAS REPEATED USING A WESTERN BLOT TEST AND THE RESULT WAS NEGATIVE. THE SAMPLE WAS REPEATED USING A DYE TEST AND THE RESULT WAS 1 NEGATIVE. THE PATIENT HAD A TOXO RESULT FROM AN ARCHITECT ANALYZER OF 0.8. THE PATIENT HAD A TOXO RESULT FROM A BIOMERIEUX ISAGA OF 0. THE PATIENT HAD A TOXO RESULT FROM A VIDAS ANALYZER OF 1 NEG. THE PATIENT HAD A TOXO RESULT FROM A CENTAUR XP ANALYZER OF 5. THE PATIENT HAD A TOXO RESULT FROM A HEMAGGLUTINATION TEST ON A (B)(4) DIAGNOSTICS ANALYZER WAS NEG. IT IS UNCLEAR IF THE RESULTS FROM THE ARCHITECT, BIOMERIEUX, VIDAS, CENTAUR, OR (B)(4) ANALYZERS CAME FROM THE SAME SAMPLE AS THE E601. CLARIFICATION HAS BEEN ASKED FOR. THERE WERE NO ADVERSE EVENTS. THE TOXO REAGENT LOT NUMBER WAS 163699 AND THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1