BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA2 CALCIUM GEN.2

    MDR report key: 7000695 · Received November 3, 2017

    Report

    Report Number
    1823260-2017-02534
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 9, 2017
    Report Date
    December 4, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHW
    PMA / PMN Number
    K113521
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION IT WAS DETERMINED THAT ANY CONNECTION BETWEEN CALCIUM RESULTS AND MISALIGNED CASSETTE LABELS CAN BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION WAS NOT ABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THE CALCIUM CASSETTES WERE REQUESTED FOR INVESTIGATION BUT WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FOR PATIENT SAMPLES COBAS 6000 C (501) MODULE SERIAL NUMBER (B)(4). THE ISSUE IS ONLY AFFECTING CALCIUM AND NO OTHER SAMPLES. THE CUSTOMER STATED THAT ON (B)(6) 2017 THE RESULTS WERE TOO LOW. THE CUSTOMER STATED THAT ON (B)(6) 2017 THE RESULTS WERE TOO HIGH. THE CUSTOMER PROVIDED EXAMPLES OF TWO PATIENT SAMPLES WITH ERRONEOUS CALCIUM RESULTS. FOR PATIENT 1 THE INITIAL CALCIUM RESULT WAS 6.6 MG/DL AND THE REPEAT RESULT WAS 10.1 MG/DL. FOR PATIENT 2 THE INITIAL CALCIUM RESULT WAS 6.9 MG/DL AND THE REPEAT RESULT WAS 9.6 MG/DL. REPEAT TESTING WAS PERFORMED ON THE SAME C501 MODULE AND DEEMED TO BE CORRECT. THERE WERE NO ADVERSE EVENTS AND THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER OBSERVED PRECIPITATE AROUND THE CALCIUM REAGENT CAP. THERE APPEARED TO BE A LEAK ON THE REAGENT CAPS WHERE THE CRYSTAL PRECIPITATE FORMED BY DROPLETS FROM THE PROBE AS IT LEFT THE CASSETTE. THIS ISSUE WAS BELIEVED TO BE DUE TO WARPING OF THE CASSETTE. THE CUSTOMER LOADED A NEW LOT OF CALCIUM FROM A NEW SHIPMENT AND ALL OF THE RESULTS ON (B)(6) 2017 DECREASED 0.3. THE RESULTS DECREASED 0.5 BASED ON DELTA CHECK VALUES. THE FIELD SERVICE ENGINEER FOUND LABELS MISALIGNED ON THREE DIFFERENT CALCIUM REAGENT CASSETTES AND REMOVED THE REAGENT CASSETTES. THE CUSTOMER RAN CALIBRATION AND QUALITY CONTROL THAT WAS WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781225 CA2 CALCIUM GEN.2 TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM CHW ROCHE DIAGNOSTICS NA 26069701

    Patients

    Seq Age Sex Outcome Treatment
    1