BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM GEN.2

    MDR report key: 22663232 · Received July 30, 2025

    Report

    Report Number
    1823260-2025-02345
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 4, 2025
    Report Date
    September 5, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHW
    UDI-DI
    04015630924936
    PMA / PMN Number
    K113521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 841368. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELDS D1-D4, G1, AND G4 WERE UPDATED. THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER BUT DID NOT FIND ANY ISSUES. DUE TO THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM RESULTS FROM THE COBAS 8000 C702 MODULE. EXAMPLE 1 INITIAL RESULT WAS 1.5 AND THE REPEAT RESULT WAS 2.14. EXAMPLE 2 INITIAL RESULT WAS 1.55 AND THE REPEAT RESULT WAS 2.23. EXAMPLE 3 INITIAL RESULT WAS 1.48 AND THE REPEAT RESULT WAS 2.17. EXAMPLE 4 INITIAL RESULT WAS 1.88 AND THE REPEAT RESULT WAS 2.3. ON (B)(6) 2025: EXAMPLE 5 INITIAL RESULT WAS 0.75 AND THE REPEAT RESULT WAS 1.54. EXAMPLE 6 INITIAL RESULT WAS 1.63 AND THE REPEAT RESULT WAS 2.0. EXAMPLE 7 INITIAL RESULT WAS 1.69 AND THE REPEAT RESULT WAS 2.3. THE UNIT OF MEASURE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549581 CALCIUM GEN.2 TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM CHW ROCHE DIAGNOSTICS CA GEN.2 04015630924936

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown