BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGE II IMMUNOASSAY

    MDR report key: 4405030 · Received January 9, 2015

    Report

    Report Number
    1823260-2015-00192
    Event Type
    Malfunction
    Date Received
    January 9, 2015
    Date of Event
    December 16, 2014
    Report Date
    January 23, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHR
    PMA / PMN Number
    K061970
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THAT THE ANALYZER IN QUESTION HAD NOT BEEN CALIBRATED SINCE (B)(6) 2014. BASED ON THIS INFORMATION, IT IS ASSUMED THAT THE REPORTED ERRONEOUS RESULTS WOULD BE ABOVE THE MEASURING RANGE WHEN MEASURED USING A CORRECTLY CALIBRATED ANALYZER.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS TESTED ON E601 ANALYZER SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR IMMUNOGLOBULIN E (IGE). THE CUSTOMER STATED THAT THEY "UNDERSTAND THAT THE MEASUREMENTS OF THIS SAMPLE WERE AFFECTED BY PROZONE." THE SAMPLE INITIALLY RESULTED AS 2300 IU/ML. THE PATIENT'S RECORD SHOWED THAT THE PATIENT HAD A PREVIOUS RESULT OF 69000 IU/ML. IT WAS ALSO NOTED THAT A PREVIOUS SAMPLE FROM THIS SAME PATIENT TESTED ON (B)(6) 2014 HAD AN IGE RESULT OF 2289 IU/ML. A VALUE OF 2939 IU/ML WHICH WAS SAID TO BE AN "ORIGINAL" WAS ALSO PROVIDED. THE SAMPLE IN QUESTION WAS THEN DILUTED MULTIPLE TIMES USING DIFFERENT DILUTION RATIOS ON (B)(6) 2014. ALL RESULTS FROM THE DILUTIONS, EXCEPT FOR FOUR, WERE GREATER THAN THE MEASURING RANGE OF THE ASSAY. THE FOLLOWING DILUTION INFORMATION AND RESULTS WERE PROVIDED FOR THE FOUR SAMPLES THAT DID NOT MEASURE OUTSIDE OF THE MEASURING RANGE OF THE ASSAY. THE SAMPLE WAS DILUTED "0/10" AND GAVE A RESULT OF 0.388 IU/ML. A DILUTION WITH A RATIO OF "2/10" RESULTED AS 2312 IU/ML. A DILUTION WITH A RATIO OF "10/10" RESULTED AS 2362 IU/ML. A DILUTION WITH A RATIO OF 1:100 RESULTED WITH A RAW VALUE OF 616.1 IU/ML WHICH WAS CALCULATED TO BE A VALUE OF 61610 IU/ML. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE SAMPLE WAS TESTED ON AN E601 ANALYZER. THE SERIAL NUMBER OF THE ANALYZER WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20284 ELECSYS IGE II IMMUNOASSAY RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E) JHR ROCHE DIAGNOSTICS NA 175624

    Patients

    Seq Age Sex Outcome Treatment
    1