BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA2

    MDR report key: 18874863 · Received March 11, 2024

    Report

    Report Number
    1823260-2024-00722
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Date of Event
    February 14, 2024
    Report Date
    March 18, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHW
    UDI-DI
    04015630924936
    PMA / PMN Number
    K113521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION DATA FROM BOTH ANALYZERS SHOWED ISSUES SINCE (B)(6) 2023. THE LAST CALIBRATION WAS SUCCESSFUL. QUALITY CONTROL DATA FROM (B)(6) 2024 TO (B)(6) 2024 WAS WITHIN RANGE. A GENERAL ANALYZER PERFORMANCE ISSUE COULD BE RULED OUT. UPON REVIEW OF THE ALARM TRACE, THERE WERE MULTIPLE FOAM DETECTION ALARMS AND ALARMS INDICATING LOW INCUBATION WATER LEVEL. MULTIPLE ABNORMAL ASPIRATION ALARMS WERE OBSERVED (B)(6) 2024 TO (B)(6) 2024. IT WAS DETERMINED THAT THE CUSTOMER STORES THEIR SAMPLES AT HIGH ROOM TEMPERATURES FOR SEVERAL HOURS. ELEVATED CALCIUM VALUES OFTEN CAME FROM SAMPLES THAT HAD BEEN STORED FOR SEVERAL DAYS. AFTER 3 DAYS OF STORAGE, CALCIUM VALUES INCREASE DUE TO EVAPORATION. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH INSUFFICIENT PRE-ANALYTIC SAMPLE HANDLING.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE FIRST C701 ANALYZER WAS PROVIDED AS (B)(6). THE SERIAL NUMBER OF THE SECOND C701 ANALYZER WAS REQUESTED, BUT NOT PROVIDED. THE CUSTOMER PROGRAMMED ADDITIONAL CARRYOVER WASHES ON THE ANALYZERS. THE FIELD SERVICE ENGINEER PERFORMED PRECISION STUDIES AND THESE WERE NOT ACCEPTABLE. PERFORMANCE TESTING WAS ALSO NOT ACCEPTABLE. THE ENGINEER CHECKED THE FILLING OF THE CUVETTES, THE GEAR PUMP PRESSURE, AND THE INCUBATION BATH WINDOW, BUT THERE WERE NO PROBLEMS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH CA2 (CALCIUM) ON TWO COBAS 8000 701 MODULE ANALYZERS. SOME RESULTS WERE FOUND TO BE TOO LOW AND OTHERS WERE TOO HIGH. THE CUSTOMER NOTED THAT DOCTORS HAVE BEEN COMPLAINING THAT CALCIUM VALUES ARE TOO HIGH. AN EXAMPLE WAS PROVIDED FOR ONE PATIENT SAMPLE WITH DISCREPANT CALCIUM RESULTS. THE SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 3 MG/DL WHEN TESTED ON A FIRST C701 ANALYZER. THE SAMPLE WAS REPEATED ON THE SECOND C701 ANALYZER, RESULTING IN A CALCIUM VALUE OF 8 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1967934 CA2 TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM CHW ROCHE DIAGNOSTICS 73362001 04015630924936

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown