BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 2990813 · Received March 5, 2013

    Report

    Report Number
    1823260-2013-01316
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    January 28, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THE INTERFERENCE WAS NOT TO ANTI- STREPTAVIDIN ANTIBODIES. THE SAMPLE INTERFERENCE LEAD TO NON-LINEAR DILUTION BEHAVIOR IN THE ESTRADIOL REAGENT. THE INTERFERENCE CAN BE REMOVED WITH PEG PRECIPITATION. IT WAS A MACROMOLECULAR INTERFERENCE TYPE, THE EXACT TYPE COULD NOT BE DETERMINED. THERE WAS NO MORE SAMPLE AVAILABLE FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ESTRADIOL RESULTS FOR ONE PATIENT ON THEIR E411 ANALYZER. THE PATIENT'S INITIAL ESTRADIOL RESULT WAS 778.0 PG/ML. THE SAMPLE WAS DILUTED 1:2 AND THE RESULT WAS 533.4 PG/ML. ON 02/01/2013, THE PATIENT HAD A NEW SAMPLE MEASURED AND THE RESULT WAS >4300 PG/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS 4246 PG/ML. THE SAMPLE WAS THEN DILUTED 1:2 AND THE RESULT WAS 2634 PG/ML. THE SAMPLE WAS THEN DILUTED 1:5 AND THE RESULT WAS 2137 PG/ML. IT WAS UNKNOWN IF ANY OF THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WERE NO REPORTS OF ANY ADVERSE EVENTS. THE ESTRADIOL REAGENT LOT NUMBER WAS 167224 AND THE EXPIRATION DATE WAS 05/30/2013. THREE PATIENT SAMPLES WERE RETURNED FOR INVESTIGATION. THE RESULTS WERE NOT SUFFICIENT TO ASSESS THE INTERFERENCE, BUT THE GENERAL PRESENCE OF AN INTERFERING FACTOR IN THE PATIENT SAMPLE WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93589 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 031 YR GONAPYRE INJECTION| CLOMID (CLOMIFENE CITRATE)