BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 502 MODULE

    MDR report key: 20772289 · Received November 25, 2024

    Report

    Report Number
    1823260-2024-03420
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    November 4, 2024
    Report Date
    December 13, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630928354
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MICROALBUMIN REAGENT LOT NUMBER WAS 788349, THE CREATININE REAGENT LOT NUMBER WAS 821402, AND THE TOTAL PROTEIN REAGENT LOT NUMBER WAS 778909. THE REAGENT EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED. THE CUSTOMER CHECKED THE SAMPLE PROBE AND DID NOT OBSERVE ANY BLOCKAGES. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT URINE SAMPLE TESTED WITH ALBT2 TINA-QUANT ALBUMIN GEN.2 (MICROALBUMIN), CREATININE PLUS VER.2, AND TOTAL PROTEIN URINE/CSF GEN.3 ON A COBAS 8000 C 502 MODULE. THE SAMPLE INITIALLY RESULTED IN THE FOLLOWING VALUES: MICROALBUMIN = 2.3 MG/L AFTER 1:20 AUTOMATIC DILUTION. CREATININE = 0 UMOL/L. TOTAL PROTEIN = 50 MG/L AFTER 1:5 AUTOMATIC DILUTION. THE SAMPLE WAS REPEATED, RESULTING IN THE FOLLOWING VALUES: MICROALBUMIN = 2630.8 MG/L AFTER 1:20 AUTOMATIC DILUTION. CREATININE = 14924 UMOL/L. TOTAL PROTEIN = 2754 MG/L AFTER 1:5 AUTOMATIC DILUTION. THE REPEAT RESULTS WERE DEEMED CORRECT AS THEY WERE CONFIRMED AFTER MULTIPLE REPEATS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786721 COBAS 8000 C 502 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630928354

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown