BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E-ELECSYS TESTOSTERONE GEN.2

    MDR report key: 3670539 · Received March 10, 2014

    Report

    Report Number
    1823260-2014-01660
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    February 11, 2014
    Report Date
    March 25, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDZ
    PMA / PMN Number
    K093421
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 REAGENT LOT IN USE AT THE TIME OF EVENT WAS 171423. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. REVIEW OF THE PROVIDED CALIBRATION AND QC DATA DID NOT INDICATE A GENERAL REAGENT ISSUE. INSTRUMENT PERFORMANCE CHECKS DID NOT PRODUCE ANY CONCERNS WITH PERFORMANCE OF THE ANALYZER.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE TESTOSTERONE RESULT FOR ONE PATIENT SAMPLE FROM THE COBAS E601 ANALYZER SERIAL NUMBER (B)(4). TWO SPECIMENS WERE DRAWN FROM THE PATIENT. THE TESTOSTERONE RESULT FROM THE FIRST TUBE WAS 663.6 NG/DL. THE REPEAT RESULT WAS 237.2 NG/DL. THE RESULT FROM THE SECOND TUBE WAS 232.2 NG/DL. THE RESULT OF 663.6 NG/DL WAS RELEASED OUTSIDE THE LABORATORY. THE REPEAT RESULT OF 237.2 NG/DL WAS BELIEVED TO BE CORRECT. THERE WAS NO HARM TO THE PATIENT. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE. HE NOTED REPLACEMENT OF THE REAGENT DID NOT RESOLVE THE PROBLEM. HE RAN PERFORMANCE TESTING ON THE ANALYZER AND PERFORMED EXTENSIVE TROUBLE SHOOTING OVER SEVERAL DAYS WHICH SHOWED NO PROBLEMS. SEVERAL PRECISION STUDIES GAVE POOR RESULTS AND INDICATED REAGENT INSTABILITY THAT COULD PRODUCE QUESTIONABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142939 COBAS E-ELECSYS TESTOSTERONE GEN.2 RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE CDZ ROCHE DIAGNOSTICS NA 171423

    Patients

    Seq Age Sex Outcome Treatment
    1 057 YR