BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM GEN. 2

    MDR report key: 19732325 · Received July 12, 2024

    Report

    Report Number
    1823260-2024-02014
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 10, 2024
    Report Date
    August 14, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHW
    UDI-DI
    04015630924035
    PMA / PMN Number
    K113521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CONTROL LEVEL WAS OUTSIDE OF RANGE ON THE DAY OF THE EVENT. A SECOND CONTROL LEVEL RECOVERED WITHIN RANGE ON THE DAY OF THE EVENT. UPON REVIEW OF THE ALARM TRACE, NO RELEVANT ALARMS WERE OBSERVED. IT WAS DETERMINED THAT THE CUSTOMER'S WATER SYSTEM UNDERWENT MAINTENANCE ACTIVITIES PRIOR TO THE EVENT. DEIONIZED WATER WAS RUN THROUGH THE SYSTEM AND THE CUSTOMER VERIFIED QUALITY CONTROL RECOVERY. NO FURTHER ISSUES OCCURRED. WATER REQUIREMENTS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE.

    Additional Manufacturer Narrative · 0

    THE C501 ANALYZER SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH CALCIUM GEN. 2 ON A COBAS 6000 C 501 ANALYZER. THE CUSTOMER NOTED THAT THE ISSUE OCCURRED AFTER MAINTENANCE WAS PERFORMED ON THE LABORATORY WATER SYSTEM. THE INITIAL VALUES WERE QUESTIONED BY A PHYSICIAN SINCE THEY DID NOT MATCH THE HISTORY OF THE PATIENTS. THE SAMPLES WERE REPEATED AND THE REPEAT VALUES WERE DEEMED CORRECT. CORRECTED REPORTS WERE ISSUED. THE FIRST SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 11.6 MG/DL AND IT REPEATED AS 9.4 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 12.5 MG/DL AND IT REPEATED AS 10.3 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861187 CALCIUM GEN. 2 TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM CHW ROCHE DIAGNOSTICS ASKU 04015630924035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown