BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 801 ANALYTICAL UNIT

    MDR report key: 23393340 · Received October 27, 2025

    Report

    Report Number
    1823260-2025-04367
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 2, 2025
    Report Date
    March 17, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K162606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT/EXPIRATION INFORMATION WAS PROVIDED AS FOLLOWS: FT3 = LOT: 84914201, EXPIRATION 30-APR-2026. FT4 = LOT: 86873201, EXPIRATION 31-MAY-2026. ANTI-TPO = LOT: 872499. CORTISOL = LOT: 885527. ESTRADIOL = LOT: 858578. ANTI-TSHR = LOT: 874011 THE ANTI-TPO, CORTISOL, ESTRADIOL, AND ANTI-TSHR REAGENT EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED. THE PATIENT'S SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE ANTI-TSHR MEASUREMENT PERFORMED ON (B)(6) 2025 WAS PERFORMED ON A SEPARATE SAMPLE COLLECTED FROM THE PATIENT AT A DIFFERENT TIME. THERE WAS NO PATIENT SAMPLE DISCREPANCY FOR ANTI-TSHR. THE PATIENT'S SAMPLE WAS PROVIDED FOR INVESTIGATION. INVESTIGATIONS OF THE SAMPLE IT CONTAINS AN INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE FT4, FT3, ANTI-TPO, CORTISOL, AND ESTRADIOL ASSAYS. 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." FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED FOR MULTIPLE ANALYTES ON A COBAS E 801 ANALYTICAL UNIT. RESULTS FOR THE FOLLOWING ASSAYS WERE AFFECTED: ELECSYS FT3 III, ELECSYS FT4 IV, ELECSYS ANTI-TPO, ELECSYS CORTISOL, ELECSYS ESTRADIOL III, AND ELECSYS ANTI-TSHR. THE ROCHE ASSAY RESULTS DID NOT COMPARE TO RESULTS MEASURED WITH THE ABBOTT METHOD. THE PATIENT SAMPLE RESULTED IN THE FOLLOWING VALUES WHEN TESTED ON THE E 801 ANALYZER ON 02-OCT-2025: FT3 = 11.60 PG/ML (REFERENCE RANGE = 2.0 - 4.4 PG/ML). FT4 = 2.81 NG/DL (REFERENCE RANGE = 0.92 - 1.68 NG/DL). ANTI-TPO = > 600 IU/ML (REFERENCE RANGE = < 34.0 IU/ML). CORTISOL = 47.80 UG/DL. ESTRADIOL = 195.0 PG/ML. ANTI-TSHR = 5.68 U/L (REFERENCE RANGE = < 1.75 U/L). THE PATIENT SAMPLE RESULTED IN THE FOLLOWING VALUES WHEN TESTED WITH THE ABBOTT METHOD ON 06-OCT-2025: FT3 = 3.06 NG/L (REFERENCE RANGE = 1.71 - 3.71 NG/L). FT4 = 12.5 NG/L (REFERENCE RANGE = 0.92 - 1.68 NG/L). ANTI-TPO = 0.88 KU/L (REFERENCE RANGE = < 5.61 KU/L). CORTISOL = 185 UG/L. ESTRADIOL = < 10 NG/L. THE PATIENT SAMPLE RESULTED IN THE FOLLOWING VALUE WHEN REPEATED ON THE E 801 ANALYZER ON 06-OCT-2025: ANTI-TSHR = 12.78 U/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2794761 COBAS E 801 ANALYTICAL UNIT IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female AMLODIPINE (TABLET, 1-0-0-0).| METOCLOPRAMIDE (TABLET, 1-1-1-0).| ONDANSETRON (TABLET, 1-0-1-0).| PRIDINOL (TABLET, 0-0-1-0).| VALPROIC ACID (1-0-0-0).