BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

    MDR report key: 14569263 · Received June 1, 2022

    Report

    Report Number
    1219913-2022-00164
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    May 16, 2022
    Report Date
    August 19, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) CUSTOMER CONTACTED THE CUSTOMER CARE CENTER (CCC) AND REPORTED FALSELY ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS ON TWO SAMPLES FROM THE SAME PATIENT COMPARED TO THE CLINICAL PICTURE AND TWO ALTERNATE METHODS. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING: "PATIENT SAMPLES MAY CONTAIN HETEROPHILIC ANTIBODIES THAT COULD REACT IN IMMUNOASSAYS TO GIVE FALSELY ELEVATED OR DEPRESSED RESULTS. THIS ASSAY IS DESIGNED TO MINIMIZE INTERFERENCE FROM HETEROPHILIC ANTIBODIES." 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." SIEMENS IS INVESTIGATING. MDR 1219913-2022-00165 WAS FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 0

    INITIAL MDR 1219913-2022-000164 WAS FILED ON 1-JUNE-2022. ADDITIONAL INFORMATION: 27-JULY-2022. AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE CUSTOMER CARE CENTER (CCC) AND REPORTED AN INITIAL, FALSELY ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT SAMPLE. THE CUSTOMER OBSERVED ELEVATED (>99TH% IFU CUTOFF 45 NG/L) ATELLICA IM TNIH VALUES ON ONE FEMALE PATIENT VERSUS VALUES OBTAINED WITH ALTERNATE METHODS. SIEMENS REVIEWED THE AVAILABLE INFORMATION TO EVALUATE FOR A POTENTIAL PRODUCT PROBLEM. QC IS WITHIN ACCEPTABLE LIMITS INDICATING A SAMPLE/PATIENT SPECIFIC INCIDENT. THE CUSTOMER'S INITIAL RESULT: 60.2 NG/L. 1ST REPEAT RESULT: 79.8 (1:2 DILUTION) 2ND REPEAT RESULT: 110.6 (1:5 DILUTION) DILUTIONS CAUSED THE RESULT TO GO HIGHER. A NEW SAMPLE TWO DAYS LATER RESULTED AS 48.5 NG/L. THE CUSTOMER RETURNED TWO SAMPLES FROM THE PATIENT TO SIEMENS FOR TESTING. SIEMENS RAN THE SAMPLES NEAT AND WITH HETEROPHILE BINDING TUBE (HBT) ON LOT 070 AND AN ALTERNATE LOT 068. RESULT UNITS (NG/L). PATIENT 1 (LOT 068) NEAT: 54 HBT: 43. PATIENT 1 (LOT 070) NEAT: 46 HBT: INSUFFICIENT SAMPLE. PATIENT 2 (LOT 068) NEAT: 50 HBT: 49 . PATIENT 2 (LOT 070) NEAT: 51 HBT: 48. THE NEAT RESULTS WERE SIMILAR TO THOSE OBSERVED BY THE CUSTOMER AND NO APPRECIABLE DIFFERENCE WAS OBSERVED BETWEEN KIT LOTS OR WITH HBT TREATMENT. THESE RESULTS DO NOT SUPPORT A HETEROPHILE ANTIBODY AS THE CAUSE OF THE ELEVATION. SIEMENS CANNOT RULE OUT ANOTHER NON-SPECIFIC INTERFERENT IN THE SAMPLE AS THE CAUSE. TROPONIN RESULTS FROM DIFFERENT ASSAY METHODS CANNOT BE USED INTERCHANGEABLY. SIEMENS ATELLICA IM TNIH HAS NO CLAIM TO MATCH RESULTS FROM ALTERNATE METHODS. ONE METHOD IN PARTICULAR IS A TROPONIN T METHOD, NOT MEASURING TROPONIN I AS IS THE SIEMENS METHOD. THE MEASURED CONCENTRATION OF CTNI IN A GIVEN SPECIMEN CAN VARY BETWEEN ASSAYS DUE TO DIFFERENCES IN ASSAY DESIGN AND METHODOLOGY. PER THE INSTRUCTIONS FOR USE (IFU), THERE ARE CONDITIONS CARDIAC AND NON-CARDIAC OTHER THAN ACUTE MYOCARDIAL INFARCTION THAT ARE KNOWN TO CAUSE MYOCARDIAL INJURY AND ELEVATED TNI VALUES. SIEMENS CANNOT RULE THIS OUT AS THE CAUSE FOR THE OBSERVATION OF PERSISTENTLY ELEVATED TROPONIN I IN THE PATIENT. NO POTENTIAL PRODUCT ISSUE IS OBSERVED. THE CUSTOMER IS OPERATIONAL. IN SECTION H6, INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED BASED ON ADDITIONAL INFORMATION. MDR 1219913-2022-00165 SUPPLEMENTAL 1 WAS FILED FOR THE SAME EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN INITIAL, FALSELY ELEVATED RESULT FOR A PATIENT SAMPLE WITH THE ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) ASSAY. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. A SECOND SAMPLE WAS COLLECTED FROM THE SAME PATIENT TWO DAYS LATER AND THE RESULT WAS STILL ELEVATED USING THE ATELLICA IM TNIH ASSAY. THE NEW SAMPLE WAS RETESTED ON TWO ALTERNATE PLATFORMS, RESULTING LOWER. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED ATELLICA IM TNIH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336091 ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) TROPONIN I IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 070 00630414006703

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female