BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 4996687 · Received August 12, 2015

    Report

    Report Number
    1823260-2015-03961
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 18, 2015
    Report Date
    September 15, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    CLARIFICATION WAS RECEIVED THAT THE REPEAT RESULT OF 2.10 UIU/ML FROM THE E170 ANALYZER WAS ON (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. A POSSIBLE ROOT CAUSE MAY BE RELATED TO INCORRECTLY POSITIONED TUBES DUE TO NO RACK ADAPTER BEING USED. THIS COULD CAUSE AN ISSUE WITH THE SAMPLE PROBE PIPETTING INSUFFICIENT SAMPLE QUANTITY CONTRIBUTING TO ERRONEOUS RESULTS.

    Additional Manufacturer Narrative · 1

    THE TSH REAGENT LOT NUMBER USED WAS 183222. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE MOST LIKELY ROOT CAUSE IS A HANDLING ISSUE (RACK ADAPTERS ARE NOT USED).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR THYROTROPIN (TSH). THE CUSTOMER COMPARED RESULTS BETWEEN A COBAS E602 ANALYZER AND A MODULAR E170 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL TSH RESULT FROM THE E602 ANALYZER WAS 0.187 UIU/ML. THE REPEAT RESULT WAS EITHER ON (B)(6) 2015 OR (B)(6) 2015 FROM THE E170 ANALYZER WAS 2.10 UIU/ML. CLARIFICATION ON THIS DATE HAS BEEN REQUESTED. THIS RESULT WAS CONSIDERED TO BE CORRECT AND WAS REPORTED OUTSIDE OF THE LABORATORY. NO ADVERSE EVENT OCCURRED. THE TSH REAGENT LOT NUMBER WAS 18382700. THE EXPIRATION DATE WAS NOT PROVIDED. IT WAS NOTED THAT THE CUSTOMER DID NOT OBSERVE ANY BUBBLE OR FOAM. THE CUSTOMER DOESN'T USE A RACK ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531382 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 079 YR