BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E-ELECSYS TESTOSTERONE GEN.2

    MDR report key: 2464064 · Received February 22, 2012

    Report

    Report Number
    1823260-2012-01025
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    February 13, 2012
    Report Date
    May 22, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDZ
    PMA / PMN Number
    K093421
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED 8 REAGENT KITS FOR INVESTIGATION. FOUR OF THE CUSTOMER KITS LONG WITH TESTOSTERONE REAGENT PACKS OF RETENTION MATERIAL OF THE SAME LOT NUMBER WERE TESTED. THE CALIBRATIONS WERE ALL SUCCESSFUL AND ALL QUALITY CONTROL WAS ACCEPTABLE. THERE WERE NO PROBLEMS IDENTIFIED WITH THE REAGENT. IT IS POSSIBLE THERE WAS AN ISSUE WITH CALIBRATOR HANDLING AT CUSTOMER SITE AS THE TESTOSTERONE CALIBRATOR SHOULD BE USED ONLY ONCE ON THE ANALYZER.

    Description of Event or Problem · 1

    AFTER CHANGING THE REAGENT PACK, THE USER EXPERIENCED ISSUES WITH QUALITY CONTROL AND RECEIVED QUESTIONABLE RESULTS FOR TESTOSTERONE GENERATION 2 (TESTOSTERONE). THE USER STATED 33 PATIENT SAMPLES WERE INVOLVED, BUT ONLY PROVIDED DATA FOR FOUR PATIENT SAMPLES. THE INITIAL TESTING WAS PERFORMED ON ANALYTICAL E MODULE SERIAL NUMBER (B)(4). THE REPEAT TESTING WAS PERFORMED ON ANALYTICAL E MODULE SERIAL NUMBER (B)(4). PATIENT SAMPLE 1 INITIAL RESULT WAS 1451 NG/DL AND THE REPEAT RESULT WAS 800.3 NG/DL. PATIENT SAMPLE 2 INITIAL RESULT WAS 1444 NG/DL AND THE REPEAT RESULT WAS 759.8 NG/DL. PATIENT SAMPLE 3 INITIAL RESULT WAS 129.4 NG/DL AND THE REPEAT RESULT WAS 32.40 NG/DL. PATIENT SAMPLE 4 INITIAL RESULT WAS 174.4 NG/DL AND THE REPEAT RESULT WAS 61.89 NG/DL. THE REPEAT RESULTS WERE CONSIDERED TO BE CORRECT. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE STATED THERE WERE BAD REAGENT PACKS AND NO INSTRUMENT FIX WAS NEEDED. HE PUT DIFFERENT REAGENT PACKS ON THE INSTRUMENT UNTIL ONE WORKED AND WAS WITHIN SPECIFICATION. THE USER RAN QUALITY CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E-ELECSYS TESTOSTERONE GEN.2 RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE CDZ ROCHE DIAGNOSTICS NA 16519902

    Patients

    Seq Age Sex Outcome Treatment
    1