BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1983132 · Received February 10, 2011

    Report

    Report Number
    1823260-2011-00747
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 17, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. ASSAY PERFORMANCE CHECKS WERE WITHIN RANGE. QUALITY CONTROLS WERE WITHIN RANGE. THE DATA MONITORS, CALIBRATION DATA, AND QUALITY CONTROL CHARTS DO NOT DEMONSTRATE A PROBLEM WITH THE INSTRUMENT. AN INSTRUMENT RELATED PROBLEM COULD NOT BE DETECTED. AN ASSAY PROBLEM WAS EXCLUDED SINCE QUALITY CONTROL WAS IN RANGE AT THE TIME OF THE EVENT. THE CUSTOMER STATED HE BELIEVES THE INITIAL ALIQUOT TUBES WERE EITHER CONTAMINATED OR THERE WAS A TECH HANDLING ISSUE AND THE WRONG SAMPLE WAS ALIQUOTED IN THE INITIAL TUBE. CONTAMINATION OF THE SAMPLE MAY BE A CAUSE FOR THIS EVENT. BOTH PATIENTS IN THIS CASE WERE NOT ADVERSELY AFFECTED.

    Description of Event or Problem · 1

    THE CUSTOMER HAD AN ON-GOING ISSUE WITH INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (BETA-HCG). HE RECEIVED QUESTIONABLE BETA HCG RESULTS FOR TWO PATIENT SAMPLES. ALL REPEAT TESTING WAS PERFORMED ON THE SAME ANALYTICAL E MODULE. PATIENT 1, TESTED (B)(6) 2011, INITIAL RESULT 104.2 MIU/ML. THE INITIAL RESULT WAS REPORTED AND THE DOCTOR QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON (B)(6) 2011 AND RECOVERED 0.100 MIU/ML. THE PATIENT WAS NOT AFFECTED BY THE EVENT. THE EXACT DATE OF TESTING FOR PATIENT 2 IS NOT KNOWN BUT TESTING OCCURRED ON APPROXIMATELY (B)(6) 2011. PATIENT 2, INITIAL BETA HCG RESULT WAS 11 MIU/ML . THE SAMPLE WAS REPEATED AND RECOVERED 0.1 MIU/ML. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY AND THE RESULT WAS QUESTIONED. AN AMENDED REPORT OF <0.1 MIU/ML WAS THEN SENT. THE PATIENT WAS NOT AFFECTED BY THE EVENT. THE REAGENT LOT NUMBER WAS 15851502. THE CUSTOMER SUSPECTED THE SAMPLES WERE CONTAMINATED OR THERE WAS A USER HANDLING ISSUE INVOLVING INCORRECT ALIQUOTING OF PATIENT SAMPLES. THE FIELD SERVICE REPRESENTATIVE DID NOT DETERMINE THE CAUSE OF THE DISCREPANCIES. HE RAN A PERFORMANCE TEST WHICH WAS ACCEPTABLE. THE CUSTOMER PERFORMED QUALITY CONTROL WHICH RECOVERED WITHIN RANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 019 YR