BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3238217 · Received July 19, 2013

    Report

    Report Number
    1823260-2013-04394
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    April 2, 2013
    Report Date
    October 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE CALIBRATION AND QUALITY CONTROL RESULTS WERE WITHIN RANGE AND THERE WAS NO INDICATION OF A REAGENT OR SYSTEM ISSUE.

    Additional Manufacturer Narrative · 1

    THE IGE REAGENT LOT NUMBER WAS 172341. A LINEARITY STUDY WAS CONDUCTED AS PART OF THE INVESTIGATION WITH 6 HIGH CONCENTRATION SAMPLES. FIVE OF THE SAMPLES WERE ABOVE THE HIGH END MEASURING RANGE. FOR THE INVESTIGATION RANGE, LINEARITY COULD BE CLEARLY SHOWN FOR ALL TESTED SAMPLES. A LINEARITY ISSUE FOR THE IGE REAGENT COULD BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE IMMUNOGLOBULIN (IGE) RESULTS OF ONE PATIENT ON THEIR E-MODULE. THE PATIENT'S FIRST SAMPLE'S INITIAL RESULT WAS >2500 IU/ML. THE FIRST SAMPLE WAS DILUTED 1:10 AND THE RESULT WAS 15803 IU/ML. THE FIRST SAMPLE WAS THEN DILUTED 1:100 AND THE RESULT WAS 22402 IU/ML. ON (B)(6) 2013, THE PATIENT'S SECOND SAMPLE'S INITIAL RESULT WAS 2214 IU/ML. THE SECOND SAMPLE WAS THEN DILUTED 1:10 AND THE RESULT WAS 13968 IU/ML. IT WAS UNKNOWN WHEN THE PATIENT HAD A THIRD SAMPLE TESTED. THE PATIENT'S THIRD SAMPLE'S INITIAL IGE RESULT WAS 1543 IU/ML. THE PATIENT'S THIRD SAMPLE WAS DILUTED 1:5 AND THE RESULT WAS 6209 IU/ML. THE PATIENT'S THIRD SAMPLE WAS DILUTED 1:10 AND THE RESULT WAS 13915 IU/ML. THE PATIENT'S THIRD SAMPLE WAS DILUTED 1:50 AND THE RESULT WAS 20369 IU/ML. THE PATIENT'S THIRD SAMPLE WAS DILUTED 1:100 AND THE RESULT WAS 21715 IU/ML. INFORMATION ABOUT WHAT RESULTS WERE REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT NOT PROVIDED. NO ADVERSE EVENTS HAD BEEN REPORTED. THE IGE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338341 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1