BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT ALBUMIN GEN.2

    MDR report key: 25303424 · Received May 27, 2026

    Report

    Report Number
    1823260-2026-02080
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DCF
    UDI-DI
    07613336120965
    PMA / PMN Number
    K101203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE C503 ANALYZER SERIAL NUMBER WAS (B)(6).

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR MULTIPLE PATIENT URINE SAMPLES TESTED FOR TINA-QUANT ALBUMIN GEN.2 (ALBT2) ON A COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER IS USING REAGENT LOT 883906 WITH AN EXPIRATION DATE OF 28-FEB-2027 AND REAGENT LOT 921496 WITH AN EXPIRATION DATE OF 31-JUL-2027. IT IS NOT CLEAR WHICH REAGENT LOT WAS USED FOR EACH RESULT. PATIENT 1 INITIAL RESULT WAS 3 MG/DL. THE REPEAT RESULT WAS 0.7 MG/DL. ON (B)(6) 2026, THE INITIAL RESULT WAS 13.8 MG/DL. THE REPEAT RESULTS WERE 28.4 MG/DL, 5.75 MG/DL, AND 8 MG/DL. FOR PATIENT 1, NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER REPLACED THE REAGENT LOT (LOT NUMBER AND EXPIRATION DATE NOT PROVIDED). A TECHNICIAN REPLACED A PROBE, AND A SPECIALIST ADDED EXTRA PRE AND POST-SAMPLING WASHES FOR THE PROBE. THE ISSUE WAS NOT RESOLVED. ON (B)(6) 2026, THE CUSTOMER ALLEGED DISCREPANT RESULTS FOR ADDITIONAL PATIENT SAMPLES (PATIENTS 2 ¿ 6). PATIENT 2 INITIAL RESULT WAS 5.46 MG/DL. THE REPEAT RESULT WAS 1.8 MG/DL. PATIENT 3 INITIAL RESULT WAS 4.88 MG/DL. THE REPEAT RESULT WAS 0.5 MG/DL. PATIENT 4 INITIAL RESULT WAS 0.04 MG/DL. THE REPEAT RESULT WAS 2.80 MG/DL. PATIENT 5 INITIAL RESULT WAS 0.13 MG/DL. THE REPEAT RESULT WAS 10.3 MG/DL. THIS SAMPLE WAS SENT TO AN EXTERNAL LABORATORY WHERE THE RESULT FROM A C 503 ANALYZER WAS 0.2 (UNIT OF MEASURE NOT PROVIDED). PATIENT 6 INITIAL RESULT WAS 27 MG/DL. THE REPEAT RESULT WAS "NEGATIVE." THE SPECIFIC RESULT WAS NOT PROVIDED. THE INSTRUMENT REPORTEDLY PRODUCED ALARMS FOR "SEVERAL" PATIENT SAMPLES. IT IS NOT KNOWN WHICH SAMPLES WERE ACCOMPANIED BY INSTRUMENT ALARMS. ON (B)(6) 2026, QC WAS OUTSIDE OF THE ACCEPTABLE RANGE. ON (B)(6) 2026, PATIENT 7 INITIAL RESULT WITH REAGENT LOT 921496 WAS 3.46 MG/DL WITH A DATA FLAG. THE REPEAT RESULT WAS 6.34 MG/DL WITH A DATA FLAG. ON (B)(6) 2026, DISCREPANT RESULTS WERE PROVIDED FOR AN ADDITIONAL PATIENT (PATIENT 7): THE INITIAL RESULT WAS 4.97 MG/DL WITH A DATA FLAG. THE REPEAT RESULT WAS 7.07 MG/DL WITH A DATA FLAG. THIS SAMPLE WAS SENT TO AN EXTERNAL LABORATORY WHERE THE RESULT FROM A C 503 ANALYZER WAS 0.2 (UNIT OF MEASURE NOT PROVIDED). ON (B)(6) 2026, PATIENT 8 INITIAL RESULT WAS 0.26 MG/DL. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 2.41 MG/DL AND 2.16 MG/DL. THE REPEAT WITH THE 3RD UNSPECIFIED REAGENT LOT NUMBER WAS 0.26 MG/DL. PATIENT 9 INITIAL RESULT WAS 2.26 MG/DL. THE REPEAT RESULT WAS 2.57 MG/DL. THIS SAMPLE WAS SENT TO AN EXTERNAL LABORATORY, WHERE THE RESULT FROM A C 503 ANALYZER WAS 0.1 (UNIT OF MEASURE NOT PROVIDED). ON (B)(6) 2026, PATIENT 9 WAS RETESTED ON THE CUSTOMER¿S C503 ANALYZER WITH A RESULT OF 9.76 MG/DL WITH A DATA FLAG. THE REPEAT RESULT WAS 0.47 MG/DL. THE SAMPLE WAS REPEATED 4 TIMES WITH RESULTS OF 8.11 MG/DL, 10 MG/DL, 2.46 MG/DL, AND 3.93 MG/DL. THE TECHNICIAN REPLACED THE REAGENT PROBES AND PERFORMED ADDITIONAL TESTING WITH PATIENT SAMPLES. ALL SAMPLES WERE REPRODUCIBLE EXCEPT FOR TWO TURBID SAMPLES: PATIENT 10 INITIAL RESULT WAS 5.89 MG/DL. THE REPEAT RESULT WAS 0.803 MG/DL. PATIENT 11 INITIAL RESULT WAS 4.05 MG/DL. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 1.15 MG/DL AND 0.770 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40006 TINA-QUANT ALBUMIN GEN.2 ALBUMIN IMMUNOLOGICAL TEST SYSTEM DCF ROCHE DIAGNOSTICS 921496, 883906 07613336120965

    Patients

    Seq Age Sex Outcome Treatment
    1