BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS P 612 PRE-ANALYTICAL SYSTEM

    MDR report key: 19819906 · Received July 24, 2024

    Report

    Report Number
    1823260-2024-02147
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 26, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    SECTION D, DEVICE IDENTIFICATION WAS UPDATED. RELEVANT FIELDS OF SECTIONS D AND G WERE UPDATED. FOR THE C501 MODULE: THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. IT WAS FOUND THAT THE ALIQUOT HEAD ON THE COBAS P 612 PRE-ANALYTICAL SYSTEM WAS LEAKING AND DILUTING THE ALIQUOT TUBES. INVESTIGATIONS DETERMINED AN ISSUE WITH THE SYRINGE CAUSED THE DILUTION. PRODUCT LABELING ADVISES CUSTOMERS TO CHECK FOR LEAKAGE, ABSENCE OF DROP FORMATION, AND THE CORRECT LIQUID DISPENSE AT THE PIPETTING UNIT.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 2 PATIENT SAMPLES TESTED FOR SODIUM (NA) ON A COBAS 6000 C501 MODULE. PATIENT 1 INITIAL RESULTS FROM THE C501 MODULE WERE 110 MMOL/L AND 109 MMOL/L. THE SAMPLE WAS REPEATED ON A C8000 SYSTEM WITH RESULTS OF 129 MMOL/L AND 133 MMOL/L. ON 03-JUL-2024 PATIENT 2 INITIAL RESULTS FROM THE C501 MODULE WERE 123 MMOL/L, 123 MMOL/L, 120 MMOL/L, AND 119 MMOL/L. THE SAMPLE WAS REPEATED ON A C8000 SYSTEM WITH RESULTS OF 139 MMOL/L AND 140 MMOL/L. THE INITIAL RESULTS FROM THE C501 MODULE WERE REPORTED OUTSIDE OF THE LABORATORY. AMENDED REPORTS WERE ISSUED FOLLOWING THE REPEAT TESTING WITH THE CORRECT RESULTS FROM THE C8000 SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230891 COBAS P 612 PRE-ANALYTICAL SYSTEM AUTOMATED PREANALYTICAL SYSTEM JQP ROCHE DIAGNOSTICS
    356099 COBAS P 612 PRE-ANALYTICAL SYSTEM AUTOMATED PREANALYTICAL SYSTEM JQP ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown