BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010

    MDR report key: 2969357 · Received February 20, 2013

    Report

    Report Number
    1823260-2013-01040
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 17, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K003178
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. BASED UPON INFORMATION PROVIDED, THE MOST LIKELY ROOT CAUSE WAS A MISADJUSTED MIXER SPEED. THE MIXER SPEED WAS FOUND TO BE TOO HIGH WHICH CAN CAUSE FOAM OR BUBBLES IN THE REAGENT. IT WAS ALSO NOTED THE CUSTOMER WAS USING A TOO LOW CENTRIFUGATION FORCE WHEN COMPARED TO THE TUBE MANUFACTURER'S RECOMMENDATIONS. AS ALL QC RESULTS WERE WITHIN RANGE, THERE WAS NO INDICATION OF A REAGENT ISSUE. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCG+SS) RESULTS FOR ONE PATIENT SAMPLE. THE INITIAL RESULT FROM AN EDTA PLASMA SAMPLE WAS < 0.100 MIU/ML WITH A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY. A SERUM SAMPLE THAT WAS DRAWN AT THE SAME TIME AS THE EDTA TUBE WAS TESTED ON (B)(6) 2013 AND THE RESULT WAS 177.7 MIU/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE HCG+SS REAGENT LOT NUMBER WAS 169563. THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73881 ELECSYS 2010 IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 039 YR