BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1728195 · Received June 18, 2010

    Report

    Report Number
    1823260-2010-03641
    Event Type
    Malfunction
    Date Received
    June 18, 2010
    Date of Event
    May 31, 2010
    Report Date
    August 26, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC CAUSE AS THE PATIENT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN VERY RARE CASES, IT IS OBSERVED THAT AN ANTIBODY USED IN ELECSYS PSA ASSAY MAY UNDERESTIMATE RARE PSA ISOFORMS. THIS IS DOCUMENTED IN PRODUCT LABELING. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED THE RESULTS OF LO (LESS THAN 10 MG/DL) AND 165 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    THE USER RECEIVED A FREE PSA RESULT THAT WAS HIGHER THAN THE TOTAL PSA RESULT FOR ONE PATIENT SAMPLE. THE INITIAL FREE PSA RESULT WAS 1.6 NG/ML AND THE INITIAL TOTAL PSA RESULT WAS 0.5 NG/ML. THE SAMPLE WAS REPEATED ON A CENTAUR ANALYZER WITH A FREE PSA RESULT OF 0.8 NG/ML AND A TOTAL PSA RESULT OF 4.5 NG/ML. NO INFORMATION WAS PROVIDED TO DETERMINE IF ERRONEOUS RESULTS WERE REPORTED OR IF THE PATIENT WAS ADVERSELY AFFECTED. THE LOT NUMBER OF THE TOTAL PSA REAGENT WAS 1111111. THE USER SUSPECTED INTERFERENCE BY AN ANTI-PSA ANTIBODY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1