BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ACTH TEST SYSTEM

    MDR report key: 9952897 · Received April 13, 2020

    Report

    Report Number
    1823260-2020-01021
    Event Type
    Malfunction
    Date Received
    April 13, 2020
    Date of Event
    March 19, 2020
    Report Date
    May 4, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CKG
    PMA / PMN Number
    K060585
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER TESTED THE SAMPLE ON A SIEMENS IMMULITE 2000 INSTRUMENT AND THE ACTH RESULT WAS > 1250 NG/L (ABOVE THE RESPECTIVE MEASURING RANGE). THE CUSTOMER PERFORMED DILUTION TESTING. PRODUCT LABELING STATES THAT DILUTION IS "NOT NECESSARY DUE TO THE BROAD MEASURING RANGE." QC RESULTS AT THE CUSTOMER SITE WERE WITHIN THE ACCEPTABLE DAILY RANGES. MAINTENANCE WAS PERFORMED AS RECOMMENDED. TWO PLASMA SAMPLES FROM THE PATIENT WERE RECEIVED FOR INVESTIGATION. THE CUSTOMER'S NON-DILUTED RESULT FOR SAMPLE 1 WAS REPRODUCED (> 2000 PG/ML). THE 2ND SAMPLE WAS NOT TESTED AS NON-DILUTED DUE TO INSUFFICIENT SAMPLE MATERIAL. THE INVESTIGATION PERFORMED A DILUTION EXPERIMENT ON BOTH SAMPLES: SAMPLE 1: DILUTION 1:10: 2766.5 PG/ML DILUTION 1:20: 2836.5 PG/ML SAMPLE 2: DILUTION 1:10: 2606.5 PG/ML DILUTION 1:20: 2780.0 PG/ML BASED ON THE RESULTS RECEIVED, THE ACTH RESULT IS CONSIDERED TO BE TRULY HIGH AND NOT DUE TO AN INTERFERENCE. A RESULT > 2000 PG/ML IS BELIEVED TO BE CORRECT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE PRODUCT MEETS SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE SAMPLE WAS REQUESTED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL CONDITION FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ACTH TEST SYSTEM (ACTH) ON A COBAS 6000 CORE UNIT. THE INITIAL RESULT FROM THE COBAS 6000 SYSTEM WAS > 2000 NG/L. AS THIS RESULT WAS NOT CONSISTENT WITH THE PATIENT'S CLINICAL CONDITION THE CUSTOMER REPEATED THE SAMPLE AND THEN TREATED THE SAMPLE WITH POLYETHYLENE GLYCOL (PEG) PRECIPITATION AND ALL THE RESULTS WERE > 2000 NG/L. THE CUSTOMER ALSO DILUTED THE SAMPLE 1:2, 1:4 AND 1:8 WITH RESULTS OF 3310 NG/L, 3894 NG/L AND 4574 NG/L RESPECTIVELY. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER SUSPECTS AN INTERFERENCE. THE CORE UNIT SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416694 ELECSYS ACTH TEST SYSTEM RADIOIMMUNOASSAY, ACTH CKG ROCHE DIAGNOSTICS NA 399347

    Patients

    Seq Age Sex Outcome Treatment
    1 PREDNISONE - DAILY