BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 3012807 · Received March 20, 2013

    Report

    Report Number
    1823260-2013-01684
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE QUALITY CONTROL DATA WAS NOT PROVIDED. THE CALIBRATION DATA WAS WITHIN EXPECTATION. THE LAST CALIBRATION WAS PERFORMED IN (B)(6) 2012, OVER FOUR MONTHS BEFORE THE EVENT, WHICH WAS NOT FOLLOWING THE RECOMMENDATIONS IN THE PACKAGE INSERT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCGB) RESULT FOR ONE PATIENT ON THEIR 2010 ANALYZER. THE CUSTOMER CONFIRMED THE TUBE WAS FILLED CORRECTLY AND THE SAMPLE WAS CLEAN AND CLEAR WITH NO APPARENT CLOTS. THE SEPARATION GEL PLUG WAS BETWEEN THE RED CELLS AND SERUM AND NOT UP THE SIDE OF THE TUBE. THE PATIENT WAS HAVING HER HCGB LEVELS CHECKED AS THE CUSTOMER SUSPECTED SHE WAS HAVING A MISCARRIAGE. WHEN THE CUSTOMER RECEIVED THE PATIENT'S INITIAL HCGB RESULT, IT WAS QUERIED BEFORE BEING REPORTED AND THE SAMPLE WAS REPEATED. THE PATIENT'S INITIAL HCGB RESULT WAS 0.333 IU/L. THE SAMPLE WAS REPEATED AND THE RESULT WAS 10000 IU/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:100 AND THE RESULT WAS 24000 IU/L AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE HCGB REAGENT LOT NUMBER WAS 169563 AND THE EXPIRATION DATE PROVIDED WAS 01/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115358 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 032 YR