BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ACTH TEST SYSTEM

    MDR report key: 6116355 · Received November 21, 2016

    Report

    Report Number
    1823260-2016-01818
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 25, 2016
    Report Date
    March 7, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CKG
    PMA / PMN Number
    K060585
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING MEDICAL BACKGROUND AND ADDITIONAL TEST RESULTS WERE PROVIDED FOR THE PATIENT: THIS PATIENT HAS BEEN DIAGNOSED AS ADRENAL INSUFFICIENCY CAUSED BY MEDICAL TREATMENT. THE PATIENT WAS INITIALLY ANALYZED AS MEMBRANOUS NEPHROPATHY AND TREATED WITH PREDNISOLONE IN 2014. IN 2015, AFTER REDUCTION OF DOSE, THE PATIENT HAD STARTED FEELING FEEBLENESS AND ADRENAL INSUFFICIENCY WAS SUSPECTED. WITH INCREASE OF PREDNISOLONE, THE PATIENT'S CONDITION GOT BETTER. BASED ON RESULTS OF RENIN AND ALDOSTERONE (NORMAL VALUES), THE PHYSICIAN DIAGNOSED HER AS ADRENAL INSUFFICIENCY CAUSED BY MEDICAL TREATMENT, NOT ADDISON'S DISEASE. IN 2016 THE PATIENT HAD A SURGERY BECAUSE OF SEROUS OVARIAN CYST. BECAUSE SHE HAD FELT FEEBLE, THE PHYSICIAN SWITCHED HER MEDICATION FROM PREDNISOLONE TO HYDROCORTISONE (30 MG/DAY). AT THIS POINT, THE PATIENT HAS BEEN THOUGHT TO NOT HAVE ADDISON¿S DISEASE. THE CUSTOMER STATED, " AT THIS POINT, PREDNISOLONE AND STEROID OINTMENT USED FOR NEPHROTIC SYNDROME TREATMENT ARE SUSPECTED AS THE CAUSE OF ENDOGENOUS SUPPRESSION OF HER TUITARY BODY/ADRENAL CORTEX. HOWEVER THERE IS A POSSIBILITY OF COMPLICATION WITH ISOLATED ACTH DEFICIENCY. IT IS HARD TO DO THE CORRECT ASSESSMENT AS LONG AS REAL ACTH CANNOT BE MEASURED. ONCE CORRECT ACTH VALUES ARE KNOWN, A CRH LOADING TEST CAN BE DONE FOR ASSESSMENT." AS CORTISOL HAS BEEN LOW, THE PHYSICIAN DOES NOT BELIEVE THE PATIENT HAS CUSHING'S DISEASE. DHEA-S => 273 NG/ML EXPECTED RANGE: 0,354 ¿ 2,56 NG/ML. TSH => 0.854 - IU/ML EXPECTED RANGE: 0,27 ¿ 4,20 - IU/ML. FT4 => 1.19 NG/DL EXPECTED RANGE: 0,93 ¿ 1,7 NG/DL. RHEUMATOID FACTOR <10, ANTINUCLEAR ANTIBODY X2560 (SPECKLED 2560'). THERE WAS NO PROBLEM WITH CALIBRATION OR QUALITY CONTROLS ON THE ANALYZER. INVESTIGATION OF THE PATIENT'S SAMPLE SENT TO THE MANUFACTURER SUGGEST A HETEROPHILIC ANTIBODY THAT INTERFERES WITH THE REACTION CAUSING A FALSELY INCREASED RESULT. THIS TYPE OF INTERFERENCE IS COVERED IN PRODUCT LABELING. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS. FURTHER CLARIFICATION OF THE OBSERVED DISCREPANCIES IS NOT POSSIBLE WITH THE AVAILABLE METHODS OR CURRENT STATE OF THE ART.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SAMPLE FROM THE PATIENT WAS TESTED FOR ACTH ON (B)(6) 2017. ACTH BY THE ROCHE METHOD WAS 348.1 PG/ML. THE RESULT BY CLEIA WAS 31.5 PG/ML, WHICH MATCHES THE CLINICAL PICTURE OF THE PATIENT. THE PATIENT ALSO HAD A CORTISOL OF 7.6 UG/DL BEFORE ADMINISTRATION OF HYDROCORTISONE. TWO SAMPLES WERE TESTED BY THE SIEMENS IMMULITE METHOD. ACTH RESULTS FOR BOTH WERE < 5 PG/ML. THESE DATA SUPPORT THE CONCLUSION THE EVENT WAS CAUSED BY A HETEROPHILIC ANTIBODY IN THE SAMPLES. FURTHER CLARIFICATION OF THE OBSERVED DISCREPANCIES IS NOT POSSIBLE WITH AVAILABLE METHODS AND THE CURRENT STATE OF THE ART.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SENT 4 SAMPLES FROM THE PATIENT TO THE MANUFACTURER. TESTING BY THE MANUFACTURER REPRODUCED THE CUSTOMER'S RESULTS. PRELIMINARY INVESTIGATIONS INDICATE A POSSIBLE NON-SPECIFIC IGM ANTIBODY IN THE SAMPLES. INVESTIGATION OF THE SAMPLES IS ONGOING. THE UNIT OF MEASURE FOR CORTISOL WAS INITIALLY REPORTED AS UG/ML. THE CUSTOMER HAS PROVIDED NEW INFORMATION THAT THE UNIT OF MEASURE IS ACTUALLY UG/DL.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED QUESTIONABLE RESULTS FOR MULTIPLE SAMPLES FROM ONE PATIENT TESTED WITH THE ELECSYS ACTH TEST SYSTEM ON A COBAS 6000 E 601 MODULE. THE SERIAL NUMBER OF THE E 601 MODULE WAS REQUESTED BUT NOT PROVIDED. REFER TO THE ATTACHMENT TO THIS MDR FOR ALL DATA. THE PHYSICIAN ASKED FOR AN INVESTIGATION BECAUSE HE BELIEVED THE ACTH RESULTS WERE UNEXPECTEDLY ELEVATED. THE RESULTS HAVE BEEN HIGH INDEPENDENT OF STEROIDS, CORTISOL, OR AN ACTH LOADING TEST. THE ELECSYS ACTH RESULTS DID NOT CHANGE WITH DILUTION. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770331 ELECSYS ACTH TEST SYSTEM RADIOIMMUNOASSAY, ACTH CKG ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR DEXAMETHASONE| HYDROCORTISONE| PREDNISOLONE| STEROID OINTMENT