BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

    MDR report key: 10988439 · Received December 10, 2020

    Report

    Report Number
    1219913-2020-00625
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 18, 2020
    Report Date
    February 5, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    UDI-DI
    00630414006703
    PMA / PMN Number
    K171566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 1219913-2020-00625 WAS FILED ON 10-DEC-2020 FOR A DISCORDANT, FALSELY ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT. (B)(6) 2021. G4 CORRECTION: THE CORRECT 510K NUMBER IS K171566 AND NOT K053020 AS INITIALLY REPORTED. ADDITIONAL INFORMATION: SIEMENS HAS COMPLETED THE INVESTIGATION. THE CUSTOMER REPORTED A REPRODUCIBLE ELEVATED ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT WHERE THE RESULT WAS LOW/NEGATIVE ON AN ALTERNATE TROPONIN ASSAY METHOD. THE PATIENT'S BIOPSY FOR MYOCARDITIS WAS CONSIDERED TO SHOW NO CARDIAC ISSUE. QUALITY CONTROL WAS ACCEPTABLE AT THE TIME THE SAMPLE WAS RUN. THE PATIENT SAMPLE RESULTS WERE REPRODUCIBLE WHICH INDICATES A SAMPLE/PATIENT SPECIFIC ISSUE. A NEW SAMPLE DRAWN POST BIOPSY WAS ELEVATED ON THE ALTERNATE ASSAY METHOD, HOWEVER THIS SAMPLE WAS NOT REPEATED WITH THE ATELLICA IM SYSTEM. THE INITIAL (PRE-BIOPSY) SAMPLE WAS REPEATED AFTER TREATMENT WITH A HETEROPHILE BINDING TUBE (HBT) AND THE RESULT DID NOT CHANGE INDICATING NO PRESENCE OF A HETEROPHILE ANTIBODY IN THE SAMPLE. THIS DOES NOT RULE OUT THE POTENTIAL OF OTHER IMMUNOCOMPLEX SUBSTANCES OR NON-SPECIFIC INTERFERENTS IN THE SAMPLE. THERE IS NO ADDITIONAL PATIENT SAMPLE AVAILABLE FOR SERIAL SAMPLE DILUTIONS OR FOR IN-HOUSE TESTING BY SIEMENS. THE ALTERNATE ASSAY METHOD RUN ON THIS PATIENT IS A TROPONIN T ASSAY METHOD AS COMPARED TO THE ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) ASSAY METHOD. DIFFERENCES IN EPITOPE RECOGNITION AND BINDING BETWEEN THE TWO ASSAY METHODS CAN CAUSE DIFFERENCES IN ANALYTE RECOVERY AND THERE IS NO CLAIM THAT THE ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) RESULTS WILL MATCH THE ALTERNATE TROPONIN T ASSAY METHOD. THE ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) INSTRUCTION FOR USE (IFU) UNDER THE DEFINITION OF A HIGH-SENSITIVITY ASSAY SECTION STATES THE FOLLOWING: "TROPONIN VALUES MUST BE USED IN THE CONTEXT OF THE PATIENT CLINICAL PRESENTATION. SERIAL SAMPLING IS RECOMMENDED TO DETECT THE TEMPORAL RISE AND FALL OF TROPONIN LEVELS CHARACTERISTIC OF AMI. THE DEMONSTRATION OF A TEMPORAL RISE AND FALL IN TROPONIN IS NEEDED TO DISTINGUISH AMI FROM TROPONIN ELEVATIONS ASSOCIATED WITH NON-AMI CONDITIONS, SUCH AS RENAL FAILURE, ARRHYTHMIAS, PULMONARY EMBOLISM, CHRONIC RENAL DISEASE, MYOCARDITIS, AND CARDIOTOXICITY." THE POTENTIAL CAUSE OF THE ELEVATED ATELLICA IM TNIH RESULTS IS UNKNOWN, HOWEVER OTHER NON-AMI CONDITION(S) CANNOT BE RULED OUT. A POTENTIAL PRODUCT PERFORMANCE ISSUE WAS NOT CONFIRMED. THE CUSTOMER IS OPERATIONAL. THE ASSAY IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDINGS CODE AND THE INVESTIGATION CONCLUSION CODES WERE REVISED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT A DISCORDANT, FALSELY ELEVATED ATELLICA IM HIGH- SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT. QUALITY CONTROL (QC) RESULTS WERE ACCEPTABLE THE DAY OF THE ISSUE. SIEMENS IS INVESTIGATING. THE INSTRUCTION FOR USE (IFU) STATES IN THE INTERPRETATION OF RESULTS SECTION: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS."

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT AND WAS QUESTIONED BY THE PHYSICIAN(S). THE CUSTOMER PERFORMED REPEAT TNIH TESTING AND THE RESULT WAS ELEVATED. THE PATIENT WAS SENT TO ANOTHER FACILITY TO UNDERGO A BIOPSY (POTENTIAL MYOCARDITIS). THE PATIENT WAS TESTED WITH AN ALTERNATE TROPONIN HS -CTN TEST METHOD, RESULTING LOWER. THE BIOPSY WAS PERFORMED AND CONFIRMED THE ABSENCE OF CARDIAC PROBLEMS. THE PATIENT'S ALTERNATE TROPONIN HS -CTN TEST METHOD RESULTED HIGHER AFTER THE PERFORMED BIOPSY. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446313 ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) TROPONIN I IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 037 00630414006703

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR