BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESTOSTERONE II

    MDR report key: 4963125 · Received August 4, 2015

    Report

    Report Number
    1823260-2015-03919
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    July 7, 2015
    Report Date
    October 29, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDZ
    PMA / PMN Number
    K093421
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SAMPLE WAS SUBMITTED FOR INVESTIGATION AND MEASURED WITH REAGENT LOT 178782. UNDILUTED TESTS WERE RUN AND MANUALLY DILUTED TESTS WERE RUN. THE CUSTOMER'S LINEARITY RESULTS WHEN PERFORMING DILUTION COULD BE REPRODUCED.

    Additional Manufacturer Narrative · 1

    DURING FURTHER INVESTIGATION OF THE SAMPLE, MEASUREMENTS PERFORMED BY LIQUID CHROMATOGRAPHY - MASS SPECTROMETRY CONFIRM THAT THE TESTOSTERONE II VALUE OF THE UNDILUTED PATIENT SAMPLE IS HIGH (> 150 NG/DL). FURTHER INVESTIGATION OF THE DATA PROVIDED BY THE CUSTOMER INDICATES AN INTERFERENCE IN THE PATIENT SAMPLE. THE INTERFERENCE MAY BE CAUSED BY EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM. THIS IS ADDRESSED IN PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT WAS CLARIFIED TO BE (B)(6) 2015. CLARIFICATION WAS RECEIVED THAT ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. CLARIFICATION WAS RECEIVED THAT THE SERIAL DILUTIONS WERE PERFORMED WITH REAGENT LOT 178782. CLARIFICATION WAS RECEIVED THAT THE PATIENT WAS NOT ADVERSELY AFFECTED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR TESTOSTERONE (TESTOSTERONE II). THE DATE OF EVENT WAS NOT PROVIDED. IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS INFORMATION HAS BEEN REQUESTED. THIS MEDWATCH WILL COVER REAGENT LOT 178782. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON REAGENT LOT 183512. THE INITIAL 2 TESTOSTERONE II RESULT WAS 1500 NG/DL WITH DATA FLAGS WHICH WAS REPEATED AND CONFIRMED. THE SAMPLE WAS REPEATED BY PERFORMING A MANUAL 1:10 DILUTION AND THE RESULT WAS 445 NG/DL. THESE 3 RESULTS WERE OBTAINED WITH REAGENT LOT 178782. THE SAMPLE WAS REPEATED AGAIN BY THIS SAME METHOD AND THE RESULT WAS 588 NG/DL WITH REAGENT LOT 183512. THE CUSTOMER THEN PERFORMED A SERIAL DILUTION WITH THE SAMPLE AND THE FOLLOWING RESULTS WERE OBTAINED: * 1:2 DILUTION RESULT WAS 1667 NG/DL * 1:4 DILUTION RESULT WAS 1218 NG/DL * 1:8 DILUTION RESULT WAS 749.2 NG/DL * 1:16 DILUTION RESULT WAS 446.7 NG/DL * 1:32 DILUTION RESULT OF 80 NG/DL (THIS RESULT WAS 2.50 NG/DL WITH A DATA FLAG PRIOR TO MULTIPLYING BY THE DILUTION FACTOR.) IT IS NOT KNOWN WHICH REAGENT LOT THE SERIAL DILUTION WAS PERFORMED WITH. THIS INFORMATION HAS BEEN REQUESTED. THE SAMPLE WAS ALSO SENT TO MASS SPECTROPHOTOMETRY AND THE RESULT WAS 540 NG/DL. THE CUSTOMER BELIEVES THIS IS THE CORRECT RESULT. IT IS NOT KNOWN IF THE PATIENT WAS ADVERSELY AFFECTED. THIS INFORMATION WAS REQUESTED. THE MODULAR E MODULE SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509002 TESTOSTERONE II RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE CDZ ROCHE DIAGNOSTICS NA 178782

    Patients

    Seq Age Sex Outcome Treatment
    1 075 YR