BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ELECSYS TSH V2

    MDR report key: 24183971 · Received January 26, 2026

    Report

    Report Number
    1823260-2026-00279
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    UDI-DI
    07613336157633
    PMA / PMN Number
    K190773
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REAGENT LOT 868935 HAD AN EXPIRATION DATE OF 30-SEP-2026. THE EXPIRATION DATES FOR REAGENT LOTS 84492900, 838516, AND 911795 WERE NOT PROVIDED. FOR 2 EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE SAMPLE WAS RECEIVED FOR INVESTIGATION. FOR 1 EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE INVESTIGATION IS ONGOING. FOR 1 EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE PATIENT SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. FOR ALL 4 EVENTS: 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?" NO. 5. DEVICE REPROCESSED AND REUSED? NO.

    Additional Manufacturer Narrative · 0

    FOR ONE EVENT, THE INVESTIGATION DETERMINED THE PATIENT'S SAMPLE CONTAINS AN INTERFERING FACTOR AGAINST THE RUTHENIUM COMPONENT OF THE ASSAY. PER 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." NO FOLLOW-UP ACTIONS WERE TAKEN. FOR THE 2ND EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE WAS DUE TO A DETECTED INTERFERENCE FACTOR IN THE SAMPLE. PER 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." AND "FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: NO FOLLOW-UP/CORRECTIVE ACTIONS WERE TAKEN. FOR THE THIRD EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION AND NO INTERFERING FACTORS WERE IDENTIFIED. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED.

    Description of Event or Problem · 0

    1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TSH V2 RESULTS FOR 4 PATIENT SAMPLES FROM COBAS E 801 ANALYTICAL UNITS. 2. PATIENT AGE RANGE: 4 YEARS, 3-ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 1-FEMALE, 1-MALE, 2-ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247435 ELECSYS TSH V2 RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS TSH 868935,84492900,838516,911795 07613336157633

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown