BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 18150198 · Received November 16, 2023

    Report

    Report Number
    1823260-2023-03629
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    October 18, 2023
    Report Date
    January 4, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) DETERMINED THAT THE EVENT WAS CAUSED BY A STUCK SAMPLE PROBE AND SALT IN THE ION-SELECTIVE ELECTRODE (ISE) HEAT BLOCK. THEY THEN ADJUSTED THE SAMPLE PROBE AND CLEANED THE HEAT BLOCK. A 21-CUP PRECISION CHECK WAS PERFORMED WITH ACCEPTABLE RESULTS. THE INVESTIGATION REVIEWED THE LAST CALIBRATION PERFORMED ON (B)(6) 2023 AND (B)(6) 2023; THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE QC DATA; THE QC WAS WITHIN -2 STANDARD DEVIATIONS (SD). THERE IS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT. THE INVESTIGATION REVIEWED THE ALARM TRACE; AN "INC. BATH WATER LEVEL SENSOR" ALARM WAS NOTED. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE GLUCOSE REAGENT LOT NUMBER IS 707366. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE POTASSIUM ELECTRODE LOT NUMBER IS U76 WITH AN EXPIRATION DATE OF 18-MAY-2024. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE MODULE. THE FSE STATED THAT THE CUSTOMER FOUND THE SAMPLE PROBE STUCK IN THE UP POSITION AND THEY ALSO FOUND SALT IN THE ION-SELECTIVE ELECTRODE (ISE) HEAT BLOCK. THE CUSTOMER ADJUSTED THE SAMPLE PROBE CLEANED THE HEAT BLOCK. THE CUSTOMER PERFORMED A 21-CUP PRECISION CHECK WITH ACCEPTABLE RESULTS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT K FOR GEN.2 AND GLUC HK GEN.3 (GLUCOSE) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 C 501 (UL) V. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE POTASSIUM RESULT WAS AUTO-RELEASED FROM THEIR LABORATORY INFORMATION SYSTEM (LIS). THE INITIAL POTASSIUM RESULT WAS NOT CORRECTED FOR SEVERAL DAYS UNTIL A CLINICIAN CALLED TO INQUIRE ABOUT IT. THE GLUCOSE RESULT WAS FLAGGED PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE INITIAL POTASSIUM RESULT WAS 2.8 MMOL/L. THE REPEAT RESULT WAS 4.8 MMOL/L. THE INITIAL GLUCOSE RESULT WAS 3 MG/DL WITH A DATA FLAG. THE REPEAT RESULT WAS 105 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764399 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown