BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-02426

    MDR report key: 6979832 · Received October 26, 2017

    Report

    Report Number
    1823260-2017-02426
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    August 30, 2017
    Report Date
    November 16, 2017
    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

    A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. THE MOST LIKELY ROOT CAUSE IS RELATED TO PRE-ANALYTICAL ISSUES SINCE SEVERAL SAMPLE ALARMS WERE DETECTED ON THE DAY OF THE EVENT. THE ALARMS THE CUSTOMER RECEIVED COULD BE CAUSED BY TEMPORARY FOAM OR BUBBLES ON THE SAMPLE SURFACE; AN INSUFFICIENT SAMPLE VOLUME; TILTED SAMPLE TUBES IN COMBINATION WITH WET TUBE WALLS; OR FIBRIN CLOTS/STRANDS CAUSED BY INADEQUATE PREANALYTICAL HANDLING. AN ADDITIONAL POSSIBLE ROOT CAUSE FOR THIS EVENT MAY BE INSUFFICIENT MAINTENANCE.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FERRITIN (FERRITIN) ON TWO COBAS 8000 E 602 MODULES. THIS MEDWATCH WILL COVER E 602 MODULE WITH SERIAL NUMBER (B)(4) (MODULE A). REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON E602 MODULE WITH SERIAL NUMBER (B)(4) (MODULE B). THE INITIAL FERRITIN RESULT FROM E602 WITH SERIAL NUMBER (B)(4) (MODULE B) WAS 3.6 NG/ML. THE SAMPLE WAS REPEATED ON E602 WITH 16M1-19 (MODULE A) AND THE RESULT WAS 2.6 NG/ML. THE RESULT OF 2.6 NG/ML WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE PATIENT. ON (B)(4) 2017 THE SAMPLE WAS REPEATED ON 2 ADDITIONAL E602 MODULES (MODULE C AND MODULE D). THE REPEAT RESULT FROM E602 MODULE C WAS 513.1 NG/ML. THE REPEAT RESULT FROM E602 MODULE D WAS 543.6 NG/ML. THE RESULT OF 543.6 NG/ML WAS BELIEVED TO BE CORRECT. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE FERRITIN REAGENT LOT NUMBER WAS 192154. THE EXPIRATION DATE WAS NOT PROVIDED. ON THE DAY OF THE EVENT THERE WERE SEVERAL INSTRUMENT ALARMS RELATED TO ABNORMAL SAMPLE PROBE MOVEMENT AND ABNORMAL SAMPLE ASPIRATION ON E602 WITH SERIAL NUMBER (B)(4).

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR