BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA2

    MDR report key: 14460921 · Received May 20, 2022

    Report

    Report Number
    1823260-2022-01449
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 20, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHW
    UDI-DI
    04015630924035
    PMA / PMN Number
    K113521
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S CALIBRATION RESULTS WERE OK. THE CUSTOMER'S QC AT 4:12 PM HAD PASSED BUT LATER IN THE EVENING (ABOUT 10:00 PM) THE QC WAS OUT OF RANGE. AFTER THE REAGENT PACK WAS REPLACED AND CALIBRATION WAS PERFORMED, THE QC WAS BACK IN RANGE. THE INVESTIGATION REVIEWED THE SYSTEM'S ALARM TRACE AND NO ABNORMALITIES WERE FOUND. THE FIELD SERVICE REPRESENTATIVE CONFIRMED THE ISSUE WAS DUE TO THE ASSAY REAGENT. AFTER TROUBLESHOOTING THE ISSUE, THE CUSTOMER WAS ABLE TO RESOLVE THE ISSUE. THE CUSTOMER PERFORMED QC WITHOUT ISSUES AND PATIENT RESULTS WERE NORMAL. AFTER SERVICE/TROUBLESHOOTING, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED TROUBLESHOOTING THE ISSUE WITH THE CUSTOMER RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CA2 RESULTS FOR 3 PATIENT SAMPLES ON 2 COBAS 6000 C (501) MODULES, SERIAL NUMBERS (B)(4). PATIENT 1 RESULTS: THE RESULTS FOR THIS SAMPLE WERE PERFORMED ON C501 MODULE, SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 6.8 MG/DL. THE REPEATED RESULT WAS 9.0 MG/DL. PATIENT 2 RESULTS: THE RESULTS FOR THIS SAMPLE WERE PERFORMED ON C501 MODULE, SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 6.7 MG/DL. THE REPEATED RESULT WAS 8.9 MG/DL. PATIENT 3 RESULTS: THE RESULTS FOR THIS SAMPLE WERE PERFORMED ON THE OTHER C501 MODULE, SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 7.0 MG/DL. THE REPEATED RESULT WAS 9.3 MG/DL. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER NOTICED OUT-OF-RANGE QC LATER IN THE EVENING AFTER THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. AFTER REVIEWING THE INITIAL PATIENT RESULTS, THE SAMPLES WERE REPEATED AND THE RESULTS WERE CORRECTED. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552206 CA2 TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM CHW ROCHE DIAGNOSTICS CA G2 61098001 04015630924035

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female