BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH ENZYMATIC CREATININE_2 (ECRE_2)

    MDR report key: 16769960 · Received April 19, 2023

    Report

    Report Number
    1219913-2023-00105
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    March 12, 2023
    Report Date
    May 26, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JFY
    UDI-DI
    00630414595795
    PMA / PMN Number
    K070727
    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 CUSTOMER OBSERVED A FALSELY DEPRESSED ENZYMATIC CREATININE_2 (ECRE_2) RESULT ON A FEMALE PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON ALTERNATE ATELLICA CH 930 ANALYZERS. THE REPEAT RESULTS WERE HIGHER THAN THE DISCORDANT RESULT. THE REPEAT RESULTS WERE CONSIDERED AS THE CORRECT RESULTS BY THE PHYSICIAN(S). CALIBRATION AND QUALITY CONTROLS (QC) WERE WITHIN THE RANGE FOR ECRE_2. THE INTERPRETATION OF RESULTS SECTION OF THE ATELLICA CH ECRE_2 INSTRUCTIONS FOR USE (IFU) STATES: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS.". SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2023-00105 ON APR 19, 2023. ADDITIONAL INFORMATION MAY 04, 2023: THE CUSTOMER OBSERVED A FALSELY DEPRESSED ENZYMATIC CREATININE_2 (ECRE_2) RESULT ON A FEMALE PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER, LOT 120236. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON ALTERNATE ATELLICA CH 930 ANALYZERS. THE REPEAT RESULTS WERE HIGHER THAN THE DISCORDANT RESULT. THE REPEAT RESULTS WERE CONSIDERED AS THE CORRECT RESULTS BY THE PHYSICIAN(S). SIEMENS WAS UNABLE TO QUERY ATELLICA CM00764 DATA FOR SAMPLE ID (B)(6). THE CUSTOMER REPORTED DISCORDANT (LOW) ATELLICA CH ECRE_2 RESULT. UNITS: MG/DL. SUBSEQUENT REPEAT TESTING OCCURRED ON ALTERNATE INSTRUMENTS (CM00329 AND CM00767). ERRORS ASSOCIATED WITH DISCORDANT RESULT: UNKNOWN SAMPLE ID: (B)(6). INITIAL RESULT: 0.24 MG/DL. ALTERNATE RESULTS: 0.84, 0.83 MG/DL. SIEMENS WAS UNABLE TO DETERMINE IF INDICATION OF REAGENT DELIVERY, OR EVIDENCE OF FOAMING ISSUE OCCURRED WITHOUT PHOTOMETER OR RESULT MONITOR DATA. (B)(6) 2023 - CONTACTS FOR DILUTION ARM CABLES AND ELECTRIC CONNECTORS WERE CLEANED. (B)(6) 2023 - REPLACED REAGENT 1 (R1) PROBE, RESET PLACEMENT OF CUVETTE SEGMENT, CORRECTED ROUTING OF TUBING TO DILUTION AND SAMPLE MIXER WASHING STATIONS. PROCESS ERRORS POSTED ON 3/12, 3/14, 3/16, 3/22, 3/23, 3/24, 3/25. DILUTION ARM : DILUTION ARM : BLEACH NOT DETECTED, DILUTION ARM : PRESSURE TRANSDUCER : SAMPLE ABNORMAL ASPIRATION, DILUTION ARM : PRESSURE TRANSDUCER : SAMPLE CLOG DETECTED, DILUTION ARM : PRESSURE TRANSDUCER : SAMPLE NOT ASPIRATED, DILUTION ARM : ARM : SAMPLE NOT DETECTED, SIEMENS PROVIDED TROUBLESHOOTING RECOMMENDATIONS TO THE CUSTOMER IF THE ISSUE REOCCURS. THE INITIAL ISSUE WAS REPORTED AS DISCORDANT (LOW) ATELLICA ENZYMATIC CREATININE_2 (ECRE_2) RESULT. SIEMENS CANNOT DEFINITIVELY DETERMINE THE CAUSE OF THIS DISCREPANT RESULT. CONTRIBUTING FACTORS SUCH AS SAMPLE INTEGRITY, PREANALYTICAL VARIABLES CANNOT BE RULED OUT. QUALITY CONTROL WAS IN RANGE AND NO ISSUES WERE NOTED WITH OTHER PATIENT SAMPLES INDICATING THAT THE INSTRUMENT AND REAGENTS WERE PERFORMING ACCEPTABLY. REPEAT OF THE SAME SAMPLES YIELDED EXPECTED RESULTS. BASED ON THE RESULTS OF THE INVESTIGATION, RETURN OF THE PATIENT SAMPLE IS NOT WARRANTED. A POTENTIAL PRODUCT ISSUE HAS NOT BEEN IDENTIFIED. CUSTOMER INSTRUMENT IS FULLY FUNCTIONAL IN SECTION H6, THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED ENZYMATIC CREATININE_2 (ECRE_2) RESULT ON A FEMALE PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON ALTERNATE ATELLICA CH 930 ANALYZERS. THE REPEAT RESULTS WERE HIGHER THAN THE DISCORDANT RESULT. THE REPEAT RESULTS WERE CONSIDERED AS THE CORRECT RESULTS BY THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED ECRE_2 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520233 ATELLICA CH ENZYMATIC CREATININE_2 (ECRE_2) ENZYMATIC CREATININE_2 ASSAY JFY SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 120236 00630414595795

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female