BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILT3 BILIRUBIN TOTAL GEN.3

    MDR report key: 25034666 · Received April 29, 2026

    Report

    Report Number
    1823260-2026-01696
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 9, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIG
    UDI-DI
    07613336235522
    PMA / PMN Number
    K131544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGES. THE INVESTIGATION DETERMINED THAT THERE MAY BE AN INTERFERENCE BY GAMMOPATHY, A KNOWN INTERFERENT. PER PRODUCT LABELING, "IN VERY RARE CASES, GAMMOPATHY, IN PARTICULAR TYPE IGM (WALDENSTRÖM¿S MACROGLOBULINEMIA), MAY CAUSE UNRELIABLE RESULTS. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS."

    Additional Manufacturer Narrative · 0

    THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE ALARM TRACE SHOWS THAT THERE WERE ALARMS RELATED TO SAMPLE SHORT S1 AND ABNORMAL ASPIRATION. THIS IS CONSISTENT WITH POOR PRE-ANALYTICAL HANDLING. QC WAS PASSING ON THE DATE OF THE EVENT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE HIGH BILT3 BILIRUBIN TOTAL GEN.3 RESULT FROM THE COBAS C 503 ANALYTICAL UNIT FOR ONE PATIENT. ON (B)(6) 2026, THE RESULT WAS ACCOMPANIED BY A DATA FLAG INDICATING THERE WAS A REACTION KINETICS ISSUE (>KIN). ON (B)(6) 2026, DURING A PATIENT FOLLOW-UP, THE INITIAL RESULT WAS 9.43 MG/DL, AND THE REPEAT RESULT WAS 1.67 MG/DL. THE SAMPLE WAS RE-CENTRIFUGED AND REPEATED ON ANOTHER C503 WITH A RESULT OF 2.57 MG/DL. THE CUSTOMER WAS ADVISED TO RE-CENTRIFUGE THE SAMPLE TWICE AND PERFORM REPLICATE TESTING. THE RESULTS WERE: 3.74 MG/DL, 3.07 MG/DL, 3.09 MG/DL, 3.03 MG/DL, AND 3.15 MG/DL. ON (B)(6) 2026, DURING A PATIENT FOLLOW-UP, THE RESULTS REMAIN INCONSISTENT WITH DATA FLAGS AND ABNORMAL REACTION CURVES. AN INVESTIGATION WAS PERFORMED ON 3 SAMPLE TYPES: 1. LI-HEPARIN PLASMA (TESTED IN 5 REPLICATES): RESULTS: 4.26 MG/DL, 6.40 MG/DL (>KIN), 7.62 MG/DL, 1.07 MG/DL, 8.07 MG/DL OBSERVATION: ALL 5 REPLICATES SHOWED ABNORMAL REACTION CURVES. 2. SERUM: RESULT: 4.00 MG/DL OBSERVATION: ABNORMAL REACTION CURVE DETECTED. 3. ETHYLENEDIAMINETETRAACETIC ACID (EDTA) PLASMA: RESULT: 2.51 MG/DL OBSERVATION: ABNORMAL REACTION CURVE DETECTED. THE INITIAL SAMPLE WAS REPEATED AS THE INITIAL RESULT DID NOT ALIGN WITH THE PATIENT'S HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418527 BILT3 BILIRUBIN TOTAL GEN.3 DIAZO COLORIMETRY, BILIRUBIN CIG ROCHE DIAGNOSTICS 89633001 07613336235522

    Patients

    Seq Age Sex Outcome Treatment
    1