BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 21605607 · Received March 14, 2025

    Report

    Report Number
    1823260-2025-00739
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    February 21, 2025
    Report Date
    April 3, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GLUC3 REAGENT LOT NUMBER WAS 803139. THE EXPIRATION DATE WAS NOT PROVIDED. THE NA AND K ELECTRODES' LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER CHECKED THE INSTRUMENT AND FOUND NO CAUSE FOR THE ISSUE. HE DECONTAMINATED AND CLEANED THE SAMPLE, THE REAGENT, AND THE ISE PROBE LINES. CALIBRATION FOR GLUC3 AND NA WAS PERFORMED WITH SUCCESSFUL RESULTS. PRECISION STUDIES AND QC WERE PERFORMED AND THEY WERE WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CALIBRATION WAS LAST PERFORMED ON 18-FEB-2025 AND IT WAS ACCEPTABLE. QC DATA WAS PROVIDED FOR 18-FEB-2025 AND IT WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER VERIFIED THAT THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH GLUC HK GEN.3 (GLUC3) ASSAY AND QUESTIONABLE ION-SELECTIVE ELECTRODE (ISE) RESULTS FOR 3 PATIENTS' SAMPLES TESTED ON A COBAS 6000 C501 (UL) V MODULE. RESULTS FOR THE FOLLOWING TESTS WERE AFFECTED: SODIUM (NA) AND POTASSIUM (K). SAMPLE 1 (PATIENT 1) WAS TESTED FOR GLUC3: INITIAL RESULT: 31 MG/DL. REPEAT RESULT: 99 MG/DL. SAMPLE 2 AND SAMPLE 3 WERE TESTED FOR NA: SAMPLE 2 (PATIENT 2): NA: INITIAL RESULT: 160 MMOL/L. REPEAT RESULT: 140 MMOL/L. SAMPLE 3 (PATIENT 3): NA: INITIAL RESULT: 160 MMOL/L. REPEAT RESULT: 139 MMOL/L. SAMPLE 4 (PATIENT 4) WAS TESTED FOR NA AND K: NA: INITIAL RESULT: 165 MMOL/L. REPEAT RESULT: 141 MMOL/L. K: INITIAL RESULT: 3.93 MMOL/L. REPEAT RESULT: 4.52 MMOL/L. QUESTIONABLE RESULTS FOR ANOTHER TEST PROMPTED THE REPEAT OF SAMPLE 1 ON ANOTHER C501. HIGH NA AND ANION GAP RESULTS PROMPTED THE REPEAT OF SAMPLE 2, SAMPLE 3, AND SAMPLE 4 ON ANOTHER C501. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULTS FOR SAMPLE 2, SAMPLE 3, AND SAMPLE 4 WAS ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415802 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male