BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM GEN. 2

    MDR report key: 19453850 · Received June 3, 2024

    Report

    Report Number
    1823260-2024-01652
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    May 14, 2024
    Report Date
    June 24, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHW
    UDI-DI
    04015630924936
    PMA / PMN Number
    K113521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALIBRATION FIRST PERFORMED ON (B)(6) 2024 FAILED. A REPEATED CALIBRATION WAS PERFORMED AND PASSED. QUALITY CONTROLS WERE ACCEPTABLE. THERE WAS NO INDICATION OF A REAGENT PERFORMANCE ISSUE. THE FIELD SERVICE ENGINEER COULD NOT DETERMINE A CAUSE. THE GEAR PUMP PRESSURE, CELL RINSE VOLUME, PROBE RINSE VOLUME, RINSE TUBING, AND PROBE ALIGNMENTS WERE CHECKED. PRECISION STUDIES WERE PERFORMED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE C 702 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CALCIUM GEN. 2 ON A COBAS 8000 C702 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.THE SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 6.8 MG/DL. SINCE THE VALUE WAS CRITICAL, THE SAMPLE WAS REPEATED.THE REPEAT CALCIUM RESULT WAS 9.3 MG/DL AND THIS VALUE WAS DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106595 CALCIUM GEN. 2 TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM CHW ROCHE DIAGNOSTICS ASKU 04015630924936

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown