BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ACTH

    MDR report key: 16272046 · Received January 31, 2023

    Report

    Report Number
    1823260-2023-00286
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    December 8, 2022
    Report Date
    April 3, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CKG
    UDI-DI
    04015630921522
    PMA / PMN Number
    K060585
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION WAS ABLE TO REPRODUCE THE CUSTOMER'S RESULT. THE INVESTIGATION ALSO PERFORMED A CONFIRMATORY TEST AND CONFIRMED THE CUSTOMER¿S RESULTS. EXCLUSION CHROMATOGRAPHY WAS PERFORMED AND THE RESULTS DID NOT SHOW THE PRESENCE OF AN INTERFERING FACTOR. THE INVESTIGATION DETERMINED THE CUSTOMER'S RESULTS WERE CORRECT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ACTH TEST SYSTEM (ACTH) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 - COBAS E 602 MODULE WITH SERIAL NUMBER: (B)(4). THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN WHO REQUESTED A RERUN. THE REPORTER STATED THAT THEY BELIEVE THERE WAS AN ANALYTICAL INTERFERENCE WITH THE RESULT FROM THIS PATIENT SAMPLE. THE PATIENT SAMPLE WAS ALSO RERUN ON THEIR OTHER E 602 MODULE WITH SERIAL NUMBER: (B)(4), BUT THE REPORTER WAS NOT ABLE TO PROVIDE THE RESULT FROM THIS MODULE. THE PATIENT SAMPLE WAS ALSO SENT TO ANOTHER LABORATORY THAT USES A SIEMENS ANALYZER. THE INITIAL RESULT FROM THE MODULE USING THE PRIMARY TUBE WAS 102.4 PG/ML. THE FIRST REPEAT RESULT FROM THE MODULE USING THE PRIMARY TUBE WAS 101.7 PG/ML. THE SECOND REPEAT RESULT FROM THE OTHER LABORATORY'S ANALYZER USING AN ALIQUOT SAMPLE WAS 64 PG/ML. THE REFERENCE RANGE IS 6-50 PG/ML. THE REPORTER DILUTED THE PATIENT SAMPLES AS PART OF THEIR INVESTIGATION. THE THIRD REPEAT RESULT FROM THE MODULE USING THE PATIENT SAMPLE IN A 1:2 DILUTION WAS 111.6 PG/ML. THE FOURTH REPEAT RESULT FROM THE MODULE USING THE PATIENT SAMPLE IN A 1:4 DILUTION WAS 124.4 PG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789362 ELECSYS ACTH RADIOIMMUNOASSAY, ACTH CKG ROCHE DIAGNOSTICS NA 606471 04015630921522

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female NORVASC 5MG| PRAVASTATIN 40MG| REMERON 30MG| SYNTHROID 50UG