BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTISOL

    MDR report key: 5107564 · Received September 28, 2015

    Report

    Report Number
    1823260-2015-04226
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Date of Event
    August 26, 2015
    Report Date
    October 23, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHG
    PMA / PMN Number
    K070788
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. CALIBRATION EFFECTS ARE CONSIDERED TO CONTRIBUTE TO THE CUSTOMER OBSERVED INITIAL LOT DEVIATION. BOTH REAGENT LOTS SHOWED HIGHER THAN EXPECTED RECOVERY FOR ONE OF THE CALIBRATORS. THE QUALITY CONTROL RECOVERY TREND WAS FOUND TO CONTRADICT THE FINDINGS OF THE PATIENT SAMPLE COMPARISON. INTERNAL METHOD COMPARISON DATA SHOWS EXCELLENT AGREEMENT BETWEEN THE REAGENT LOTS IN QUESTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR A TOTAL OF 28 PATIENT SALIVA SAMPLES TESTED FOR CORTISOL. THE SAMPLES WERE BEING TESTED AS PART OF A LOT TO LOT CORRELATION ON THE E601 ANALYZER. OF THE 28 SAMPLES, FOURTEEN WERE FOUND TO HAVE ERRONEOUS RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS OBTAINED WITH THE CURRENT REAGENT LOT NUMBER 178322 WERE HIGH COMPARED TO RESULTS FROM THE NEW REAGENT LOT NUMBER 185380. THE CUSTOMER STATED THAT THEY HAD NOTICED WITH INCREASED FREQUENCY THAT CONTROLS WERE OUTSIDE OF RANGE AND PATIENT RESULTS HAD BEEN INCREASING. THE RESULTS OBTAINED WITH THE CURRENT LOT 178322 WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS OBTAINED WITH NEW LOT 185380 WERE BELIEVED TO BE CORRECT. THE PATHOLOGIST DID NOT DEEM THE DIFFERENCE IN RESULTS TO BE CLINICALLY SIGNIFICANT, SO THE RESULTS THAT HAD BEEN REPORTED OUTSIDE OF THE LABORATORY WERE NOT CORRECTED. THE FIRST PATIENT SAMPLE RESULTED AS 0.396 UG/DL WHEN TESTED WITH THE CURRENT LOT AND RESULTED AS 0.241 UG/DL WHEN TESTED WITH THE NEW LOT. THE SECOND PATIENT SAMPLE RESULTED AS 0.353 UG/DL WHEN TESTED WITH THE CURRENT LOT AND RESULTED AS 0.203 UG/DL WHEN TESTED WITH THE NEW LOT. THE THIRD PATIENT SAMPLE RESULTED AS 0.286 UG/DL WHEN TESTED WITH THE CURRENT LOT AND RESULTED AS 0.176 UG/DL WHEN TESTED WITH THE NEW LOT. THE FOURTH PATIENT SAMPLE RESULTED AS 0.864 UG/DL WHEN TESTED WITH THE CURRENT LOT AND RESULTED AS 0.546 UG/DL WHEN TESTED WITH THE NEW LOT ON (B)(6) 2015. THIS PATIENT WAS A (B)(6). THE FIFTH PATIENT SAMPLE RESULTED AS 0.140 UG/DL WHEN TESTED WITH THE CURRENT LOT AND RESULTED AS 0.018 UG/DL WHEN TESTED WITH THE NEW LOT ON (B)(6) 2015. THE SIXTH PATIENT SAMPLE RESULTED AS 0.222 UG/DL WHEN TESTED WITH THE CURRENT LOT AND RESULTED AS 0.071 UG/DL WHEN TESTED WITH THE NEW LOT ON (B)(6) 2015. THE SEVENTH PATIENT SAMPLE RESULTED AS 0.483 UG/DL WHEN TESTED WITH THE CURRENT LOT AND RESULTED AS 0.232 UG/DL WHEN TESTED WITH THE NEW LOT ON (B)(6) 2015. THE EIGHTH PATIENT SAMPLE RESULTED AS 63.44 UG/DL WHEN TESTED WITH THE CURRENT LOT AND RESULTED AS 39.30 UG/DL WHEN TESTED WITH THE NEW LOT ON (B)(6) 2015. THE NINTH PATIENT SAMPLE RESULTED AS 0.191 UG/DL WHEN TESTED WITH THE CURRENT LOT AND RESULTED AS 0.037 UG/DL WHEN TESTED WITH THE NEW LOT ON (B)(6) 2015. THE TENTH PATIENT SAMPLE RESULTED AS 0.452 UG/DL WHEN TESTED WITH THE CURRENT LOT AND RESULTED AS 0.256 UG/DL WHEN TESTED WITH THE NEW LOT ON (B)(6) 2015. THE ELEVENTH PATIENT SAMPLE RESULTED AS 0.297 UG/DL WHEN TESTED WITH THE CURRENT LOT AND RESULTED AS 0.183 UG/DL WHEN TESTED WITH THE NEW LOT ON (B)(6) 2015. THE TWELFTH PATIENT SAMPLE RESULTED AS 0.300 UG/DL WHEN TESTED WITH THE CURRENT LOT AND RESULTED AS 0.157 UG/DL WHEN TESTED WITH THE NEW LOT ON (B)(6) 2015. THE THIRTEENTH PATIENT SAMPLE RESULTED AS 0.774 UG/DL WHEN TESTED WITH THE CURRENT LOT AND RESULTED AS 0.485 UG/DL WHEN TESTED WITH THE NEW LOT ON (B)(6) 2015. THE FOURTEENTH PATIENT SAMPLE RESULTED AS 0.164 UG/DL WHEN TESTED WITH THE CURRENT LOT AND RESULTED AS 0.020 UG/DL WHEN TESTED WITH THE NEW LOT ON (B)(6) 2015. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE E601 ANALYZER SERIAL NUMBER WAS (B)(4). THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THE ISSUE WAS CAUSED BY THE OLDER, CURRENT REAGENT LOT NUMBER. THE CUSTOMER SWITCHED TO THE NEW LOT NUMBER. CALIBRATION AND CONTROLS PASSED ACCORDING TO THE CUSTOMER'S RANGES. THE FIELD APPLICATION SPECIALIST DETERMINED THAT THE OLDER, CURRENT LOT WAS NOT RECOVERING AS EXPECTED. THE NEW LOT NUMBER WAS RECOVERING WITHIN ACCEPTABLE LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638438 CORTISOL ENZYME IMMUNOASSAY, CORTISOL, SALIVARY NHG ROCHE DIAGNOSTICS NA 17832201

    Patients

    Seq Age Sex Outcome Treatment
    1