BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 19080340 · Received April 10, 2024

    Report

    Report Number
    1823260-2024-01087
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 15, 2024
    Report Date
    April 10, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CHOLESTEROL REAGENT LOT NUMBER IS 760435 WITH AN EXPIRATION DATE OF 31-AUG-2024. THE LDL-CHOLESTEROL REAGENT LOT NUMBER IS 747015 WITH AN EXPIRATION DATE OF 31-JUL-2025. THE INVESTIGATION REVIEWED THE CHOLESTEROL CALIBRATION DATA FROM 03-JAN-2024 TO 13-MAR-2024; THE LAST CALIBRATION WAS WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE LDL-CHOLESTEROL CALIBRATION DATA FROM 22-OCT-2023 TO 30-MAR-2024. THE RELATED CALIBRATION WAS PERFORMED ON 13-MAR-2024; THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE CHOLESTEROL QC RECOVERY DATA USING ROCHE'S UNIVERSAL CONTROL AND AN ASSAYED CHEMISTRY PREMIUM PLUS QUALITY CONTROL. THE QCS WERE WITHIN THE +/- 2 STANDARD DEVIATION RANGE BUT THE QC RECOVERY WAS NOT PROVIDED FOR THE REPORTED DATE OF EVENT. THE INVESTIGATION REVIEWED THE LDL-CHOLESTEROL QC RECOVERY DATA USING ROCHE'S UNIVERSAL CONTROL. THE QCS WERE WITHIN THE +/- 2 STANDARD DEVIATION RANGE BUT THE QC RECOVERY WAS NOT PROVIDED FOR THE REPORTED DATE OF EVENT. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE MODULE AND FOUND SEVERAL HOSES OF THE WASHING ARM WERE PRESSED WHICH CRACKED AND CAUSED ERRONEOUS ASPIRATION, DISPENSING, AND OVERFLOW OF THE CUVETTES, AND IN SOME CASES CAUSING RANDOM DILUTED REACTIONS. THE FSE THEN PERFORMED INTERVENTIONS. THE INVESTIGATION DETERMINED THE EVENT WAS CAUSED BY AN INSTRUMENT-RELATED ISSUE (WASHING ARM HAD SEVERAL HOSES PRESSED). AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE CHOL HICO GEN.2 (CHOL2) ASSAY AND LOW DENSITY LIPOPROTEINS-CHOLESTEROL GEN.3 (LDL3) ASSAY RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS 6000 C501 MODULE. SAMPLE 1 THE INITIAL CHOLESTEROL RESULT WAS 112 MG/DL. THE REPEAT RESULT WAS 236 MG/DL. SAMPLE 2 THE INITIAL LDL-CHOLESTEROL RESULT WAS 27 MG/DL. THE REPEAT RESULT WAS 184 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408163 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown