BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS DHEA-S

    MDR report key: 24774821 · Received April 3, 2026

    Report

    Report Number
    1823260-2026-01206
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 9, 2026
    Report Date
    May 28, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JKC
    UDI-DI
    04015630940387
    PMA / PMN Number
    K003174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELDS D1, D2, AND D4 HAVE BEEN UPDATED. SAMPLE MATERIAL WAS REQUESTED, HOWEVER, IT WAS NOT AVAILABLE. THEREFORE, FURTHER INVESTIGATION COULD NOT BE PERFORMED. THE ISSUE IS CONSISTENT WITH A KNOWN INTERFERING FACTOR MENTIONED IN THE PRODUCT LABELING: "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF INTERFERENCE WITH THE ELECSYS DHEA-S, ELECSYS ESTRADIOL III ASSAY, AND ELECSYS TESTOSTERONE II ASSAY FOR A PATIENT SAMPLE TESTED ON THE COBAS E 801 MODULE. THIS MEDWATCH WILL APPLY TO THE ELECSYS DHEA-S ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS ESTRADIOL III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS TESTOSTERONE II ASSAY. BASED ON THE PREVIOUS RESULTS AND CONSIDERING THAT NOTHING WAS VISIBLE ON IMAGING AND THAT THE PATIENT STATED SHE WAS NOT TAKING ANY MEDICATION, THE DOCTOR REQUESTED THAT THE TESTS BE PERFORMED AT ANOTHER LABORATORY (ONE THAT USES CHEMILUMINESCENCE). THE FOLLOWING VALUES WERE OBTAINED AND WERE CONSIDERED NORMAL: (B)(6) 2026: ESTRADIOL 104 PG/ML, DHEA-S 90 G/DL, AND TESTOSTERONE 24 NG/DL. THE SAME SAMPLE WAS REPEATED AT THE CUSTOMER SITE AND GENERATED THE FOLLOWING RESULTS: ESTRADIOL 451 PG/ML, DHEA-S >1000 G/DL, AND TESTOSTERONE 126 NG/DL. A POLYETHYLENE GLYCOL (PEG) PRECIPITATION WAS PERFORMED AFTER MIXING EQUAL PARTS OF SERUM AND 25% W/V PEG, AND THE VALUES WERE: ESTRADIOL 170 PG/ML, DHEA-S 100 G/DL, AND TESTOSTERONE 30 NG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542032 ELECSYS DHEA-S DEHYDROEPIANDROSTERONE TEST SYSTEM JKC ROCHE DIAGNOSTICS DHEA-S 857267 04015630940387

    Patients

    Seq Age Sex Outcome Treatment
    1