BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESTOSTERONE

    MDR report key: 2437887 · Received February 3, 2012

    Report

    Report Number
    1823260-2012-00653
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    January 18, 2012
    Report Date
    April 17, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDZ
    PMA / PMN Number
    K093421
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THE REAGENT KIT USED WAS LIKELY DEFECTIVE AS INDICATED BY THE QUALITY CONTROLS WHICH WERE OUT OF SPECIFICATIONS WITH THIS KIT PRIOR TO THE EVENT. FURTHER INVESTIGATIONS WERE NOT POSSIBLE AS THE KIT HAD BEEN DISCARDED BY THE CUSTOMER. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ONE HUNDRED TWENTY ONE PATIENT SAMPLES TESTED FOR TESTOSTERONE. OF THE ONE HUNDRED TWENTY ONE SAMPLES, SIXTY EIGHT WERE FOUND TO HAVE ERRONEOUS TESTOSTERONE RESULTS. ALL SAMPLES WERE REPEATED TWICE WITH THE FIRST REPEATS PERFORMED ON ANOTHER E170 ANALYZER (SERIAL NUMBER (B)(4)) AND THE SECOND REPEATS PERFORMED ON THE SAME E170 ANALYZER (SERIAL NUMBER (B)(4)). THE CUSTOMER BELIEVED THE SECOND REPEAT VALUE TO BE CORRECT AND CORRECTED REPORTS WERE ISSUED FOR THESE VALUES EXCEPT FOR SAMPLE IDS (B)(6). FOR SAMPLE IDS (B)(6), THE FIRST REPEAT VALUE WAS CONSIDERED CORRECT AND CORRECTED REPORTS WERE ISSUED FOR THESE VALUES. PLEASE REFERENCE THE ATTACHMENT TO THIS MEDWATCH FOR THE PATIENT DATA. NO PATIENTS WERE ADVERSELY AFFECTED BY THE EVENT. THE E170 SERIAL NUMBER IS (B)(4). THE CUSTOMER DECLINED A SERVICE VISIT AND DETERMINED THAT THE ISSUE WAS ATTRIBUTED TO A "BAD" REAGENT PACK. THE CUSTOMER RAN QUALITY CONTROL ON THE PACK ON (B)(6) 2012 AND FOUND THAT THE CONTROLS WERE OUTSIDE OF THEIR RANGE. THIS PROMPTED THE CUSTOMER TO REPEAT THE SAMPLES ON A DIFFERENT PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESTOSTERONE RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE CDZ ROCHE DIAGNOSTICS NA 16369602

    Patients

    Seq Age Sex Outcome Treatment
    1