BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-02057

    MDR report key: 6889499 · Received September 25, 2017

    Report

    Report Number
    1823260-2017-02057
    Event Type
    Malfunction
    Date Received
    September 25, 2017
    Date of Event
    August 25, 2017
    Report Date
    September 25, 2017
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR THREE PATIENT SAMPLES TESTED FOR FERR4 TINA-QUANT FERRITIN GEN.4 (FERR) ON A COBAS 8000 C (701) MODULE - C701. OF THE THREE SAMPLES, TWO HAD ERRONEOUS INITIAL FERR RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE WAS RUN IN A SAMPLE CUP AND INITIALLY RESULTED AS 4.4 NG/ML. THE 4.4 NG/ML VALUE WAS REPORTED OUTSIDE OF THE LABORATORY AS < 5 NG/ML. THE DOCTOR REQUESTED FOR A NEW SAMPLE TO BE COLLECTED FROM THE PATIENT. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2017 AND TESTED, RESULTING AS 21 NG/ML. THE DOCTOR THEN REQUESTED A REPEAT OF THE ORIGINAL SAMPLE. THE ORIGINAL SAMPLE WAS REPEATED IN A SAMPLE CUP AND IT RESULTED AS 20.4 NG/ML ON (B)(6) 2017. THE ORIGINAL SAMPLE VOLUME WAS OBSERVED TO BE LOW, IT WAS HEMOLYZED, AND CONTAINED DEBRIS. THE SAMPLE WAS TESTED IN A SAMPLE CUP DUE TO THE LOW VOLUME. THE SECOND SAMPLE, FROM AN (B)(6) FEMALE PATIENT BORN ON (B)(6), INITIALLY RESULTED AS 3.90 NG/ML ON (B)(6) 2017. THE 3.90 NG/ML VALUE WAS REPORTED OUTSIDE OF THE LABORATORY AS < 5 NG/ML. THE DOCTOR QUESTIONED THE RESULT, SO THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 50.1 NG/ML ON(B)(6) 2017. THE SAMPLE VOLUME WAS VERY LOW. NO ADVERSE EVENTS WERE ALLEGED. THE FERR REAGENT LOT NUMBER WAS 232970; THE EXPIRATION DATE WAS NOT PROVIDED. THE LAST CALIBRATION WAS PERFORMED ON (B)(6) 2017 AND WAS SUCCESSFUL. QUALITY CONTROL RESULTS FROM (B)(6) 2017 ARE FINE. THE MOST LIKELY ROOT CAUSE FOR THE EVENT IS THE LOW SAMPLE VOLUME.

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR