BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM GEN. 2

    MDR report key: 20214895 · Received September 13, 2024

    Report

    Report Number
    1823260-2024-02666
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 8, 2024
    Report Date
    November 11, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHW
    UDI-DI
    04015630924936
    PMA / PMN Number
    K113521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVIEWED THE 20-AUG-2024 CALIBRATION DATA; THE CALIBRATION WAS ACCEPTABLE BUT THE SIGNALS CHANGED COMPARED TO THE PREVIOUS REAGENT LOT. THE INVESTIGATION REVIEWED THE QC RECOVERY; THE RECOVERIES WERE ERRATIC AND SHOWED BOTH HIGH AND LOW RECOVERIES EITHER AT THE 2 STANDARD DEVIATION RANGE OR CLOSE TO OUT OF RANGE. THIS IS AN INDICATION OF A POSSIBLE REAGENT ISSUE. THE FIELD SERVICE REPRESENTATIVE INSPECTED THE MODULE AND INDICATED THAT THE RECOVERY ISSUE STARTED WITH THE REPORTED REAGENT LOT. THE CUSTOMER CHANGED THE REAGENT LOT AND OBTAINED ACCEPTABLE QC RESULTS. THE CUSTOMER DID NOT REPORT ANY OTHER ISSUES AFTER SERVICE. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE COBAS 8000 C702 MODULE IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FROM 567 PATIENT SAMPLES TESTED ON THE COBAS 8000 C702 MODULE. THE REPORTER STATED THAT THEY NOTED THE VARIATION IN QC AND PATIENT RESULTS WHEN THEY STARTED USING THE REPORTED REAGENT LOT. THE REPORTER WAS ABLE TO PROVIDE ONE PATIENT SAMPLE WITH DISCREPANT RESULTS: THE INITIAL RESULT WAS 9.6 MG/DL. THE REPEAT RESULT WAS 7.7 MG/DL. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AS IT WAS DEEMED INCORRECT. THE REPEAT RESULT WAS DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113998 CALCIUM GEN. 2 TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM CHW ROCHE DIAGNOSTICS CA GEN.2 790795 04015630924936

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown