BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 5834379 · Received July 29, 2016

    Report

    Report Number
    1823260-2016-01092
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    June 6, 2016
    Report Date
    July 29, 2016
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR ESTRADIOL ON AN E601 ANALYZER. THE SAMPLE INITIALLY RESULTED AS 482.9 PG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT. THE PHYSICIAN ASKED FOR A NEW MEASUREMENT OF THE SAMPLE SINCE THE INITIAL VALUE WAS NOT IN AGREEMENT WITH THE CLINICAL PICTURE OF THE PATIENT. THE SAMPLE WAS THAWED AND PRIOR TO REPEATING THE SAMPLE, IT WAS RE-CENTRIFUGED. AFTER RE-CENTRIFUGATION, IT WAS NOTED THAT THE SAMPLE WAS HEMOLYZED. THE SAMPLE WAS REPEATED ON (B)(6) 2016, RESULTING AS 50.36 PG/ML. THE SAMPLE WAS REPEATED A SECOND TIME ON (B)(6) 2016, RESULTING AS 34.30 PG/ML. THE SAMPLE WAS REPEATED A THIRD TIME ON (B)(6) 2016, RESULTING AS 27.56 PG/ML. THE SAMPLE WAS ALSO REPEATED A FOURTH TIME ON (B)(6) 2016, RESULTING AS 36.08 PG/ML. THE REPEAT VALUE OF 34.30 PG/ML WAS BELIEVED TO BE THE CORRECT VALUE AND A CORRECTED REPORT WAS SENT TO THE PATIENT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE ESTRADIOL REAGENT LOT NUMBER WAS 120670. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. IT WAS NOTED THAT SEVERAL LIQUID LEVEL DETECTION ALARMS WERE SEEN ON (B)(6) 2016. THE CUSTOMER CLEANED THE PROBES. THE FIELD APPLICATIONS SPECIALIST RAN PERFORMANCE TESTING AND THIS FAILED. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. SINCE PERFORMANCE TESTING FAILED, AN INSTRUMENT ISSUE IS THE MOST LIKELY ROOT CAUSE. A GENERAL REAGENT ISSUE WAS NOT EVIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485857 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR