BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH CALCIUM_2 (CA_2)

    MDR report key: 16608509 · Received March 24, 2023

    Report

    Report Number
    1219913-2023-00057
    Event Type
    Malfunction
    Date Received
    March 24, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 20, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CJY
    UDI-DI
    00630414220697
    PMA / PMN Number
    K083386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2023-00057 ON MAR 24, 2023. ADDITIONAL INFORMATION MAR 27, 2023: IN SECTION B3, THE DATE OF EVENT WAS CHANGED TO THE CORRECT DATE MAR 13, 2023. ADDITIONAL INFORMATION APR 19, 2023: AN OUTSIDE THE UNITED STATES CUSTOMER OBSERVED A FALSELY DEPRESSED CALCIUM_2 (CA_2) RESULT ON A FEMALE PATIENT SAMPLE ON ATELLICA CH ANALYSER, LOT 221777. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPROCESSED ON ORIGINAL INSTRUMENT. THE REPEAT RESULT WAS HIGHER THAN THE INITIAL RESULT AND CONSIDERED AS CORRECT. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN. REPEAT OF THE SAME SAMPLE YIELDED EXPECTED RESULT. RETURN OF THE PATIENT SAMPLE WAS NOT REQUIRED OR WARRANTED BASED UPON THE RESULTS OF THE INVESTIGATION. SIEMENS HAS REVIEWED THE INFORMATION PROVIDED AND CONCLUDES THAT IT IS NOT A REAGENT LOT OR METHOD ISSUE. THERE IS NO EVIDENCE OF A PRODUCT NONCONFORMANCE. A REVIEW OF THE CUSTOMER'S QUALITY CONTROL (QC) SHOWED CONSISTENT RECOVERY WITHIN A 3RD (STANDARD DEVIATION) PEER RANGE INDICATING THE ISSUE IS NOT RELATED TO A REAGENT NONCONFORMANCE. THE INTERMITTENT NATURE OF THE ISSUE IS CONSISTENT WITH INSTRUMENT RELATED CAUSES. INVESTIGATION: THE CUSTOMER SERVICE ENGINEER (CSE) REPLACED THE SAMPLE PROBE, THE REAGENT 1 (R1) PROBE, DILUTION PROBE, AND THE SAMPLE MIXER IMPELLER. THE CSE ALSO ADJUSTED THE LAMP VOLTAGE AND PERFORMED INSTRUMENT ALIGNMENTS. THE PARTS REPLACED BY THE CSE IS PART OF NORMAL TROUBLESHOOTING/MAINTENANCE FOR ISSUES OF THIS NATURE, THEREFORE, RETURN OF THE FAILED PARTS IS NOT WARRANTED. THE CUSTOMER CONTINUED TO RUN THE INSTRUMENT AND HAD NO FURTHER ISSUES POST SERVICE. BASED ON THE INFORMATION PROVIDED AND A REVIEW OF THE INSTRUMENT DATA, SIEMENS CONCLUDES THE LIKELY CAUSE OF THE DISCREPANT ATELLICA CH CA_2 RESULT WAS DUE TO INSTRUMENT RELATED ISSUES. THE CSE RESOLVED THE ISSUE BY REPLACING THE SAMPLE PROBE, THE R1 PROBE, THE DILUTION PROBE, AND THE SAMPLE MIXER. THERE IS INSUFFICIENT INFORMATION PROVIDED FOR SIEMENS TO DETERMINE WHICH SPECIFIC ACTION TAKEN BY THE CSE ULTIMATELY RESOLVED THE ISSUE. THE CUSTOMER HAS OBSERVED NO FURTHER ISSUE RELATED TO THIS COMPLAINT POST SERVICE. THE CUSTOMER IS CURRENTLY FULLY OPERATIONAL, AND THE INSTRUMENT IS WORKING AS EXPECTED. THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE THE UNITED STATES CUSTOMER OBSERVED A FALSELY DEPRESSED CALCIUM_2 (CA_2,) RESULT ON A FEMALE PATIENT SAMPLE ON ATELLICA CH ANALYSER, LOT 221777. THE SAMPLE WAS REPROCESSED ON ORIGINAL INSTRUMENT. THE REPEAT RESULT WAS HIGHER THAN THE INITIAL RESULT. THE REPEAT RESULT WAS CONSIDERED CORRECT. QUALITY CONTROLS (QC) WERE IN RANGE AT THE TIME OF THE EVENT. THE INTERPRETATION OF RESULTS SECTION OF THE ATELLICA CH CA_2 INSTRUCTIONS FOR USE STATES (IFU): "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS.". THE LIMITATIONS SECTION OF THE ATELLICA CH CA_2 INSTRUCTIONS FOR USE STATES (IFU): "THE ATELLICA CH CA_2 ASSAY IS LIMITED TO THE DETECTION OF CALCIUM IN HUMAN SERUM, PLASMA (LITHIUM HEPARIN) AND URINE.". SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED CALCIUM_2 (CA_2,) RESULT ON A FEMALE PATIENT SAMPLE ON ATELLICA CH ANALYSER, LOT 221777. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPROCESSED ON ORIGINAL INSTRUMENT. THE REPEAT RESULT WAS HIGHER THAN THE INITIAL RESULT. THE REPEAT RESULT WAS CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CA_2 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472204 ATELLICA CH CALCIUM_2 (CA_2) CALCIUM_2 (CA_2) ASSAY CJY SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 221777 00630414220697

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female