BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 2864419 · Received December 10, 2012

    Report

    Report Number
    1823260-2012-06208
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 27, 2012
    Report Date
    January 2, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. A TOO SHORT CLOTTING TIME WAS A POSSIBLE CAUSE AS THE CUSTOMER WAS ONLY ALLOWING A CLOTTING TIME OF 5 MINUTES. A GENERAL INSTRUMENT ISSUE WAS NOT SUSPECTED AS THE ALARM TRACE AND ASSAY PERFORMANCE CHECK DATA WAS ACCEPTABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCG+SS) RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.334 MIU/ML AND WAS REPORTED TO THE DOCTOR. AFTER THE DOCTOR INTERVIEWED THE PATIENT AND FOUND THAT SHE WAS PREGNANT, THE DOCTOR ASKED THE LABORATORY TO REPEAT TESTING. THE LABORATORY REPEATED THE SAME TUBE AND THE RESULT WAS >10000 MIU/ML WITH A DATA FLAG. THE SAMPLE AUTOMATICALLY REPEATED WITH A 1:10 DILUTION AND THE RESULT WAS 27200 MIU/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED A THIRD TIME AND THE RESULT WAS 28536 MIU/ML WITH A DATA FLAG. 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
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 040 YR