BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 17270964 · Received July 6, 2023

    Report

    Report Number
    1823260-2023-02193
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    March 20, 2023
    Report Date
    November 15, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER ALLEGED 5 ADDITIONAL DISCREPANT RESULTS FOR PATIENTS' SAMPLES TESTED FOR TROPONIN T HS. PATIENT 5: ON (B)(6) 2023: INITIAL RESULT: 13.20 NG/L (LINE 2) 1ST RERUN RESULT: 19 NG/L (LINE 1) 2ND RERUN RESULT: 17.70 NG/L (LINE 3). PATIENT 6: ON (B)(6) 2023: INITIAL RESULT: 6.70 NG/L (LINE 1) 1ST RERUN RESULT: 16.60 NG/L (LINE 2) 2ND RERUN RESULT: 5.95 NG/L (LINE 3). PATIENT 7: ON (B)(6) 2023: INITIAL RESULT: 36.90 NG/L (LINE 3) 1ST RERUN RESULT: 91.20 NG/L (LINE 2) 2ND RERUN RESULT: 37.60 NG/L (LINE 1). PATIENT 8: ON (B)(6) 2023: INITIAL RESULT: 20 NG/L (LINE 2) 1ST RERUN RESULT: 15.10 NG/L (LINE 1) 2ND RERUN RESULT: 14.70 NG/L (LINE 3). PATIENT 9: ON (B)(6) 2023: INITIAL RESULT: 18.50 NG/L (LINE 2) 1ST RERUN RESULT: 13.70 NG/L (LINE 1) 2ND RERUN RESULT: 14.30 NG/L (LINE 3). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE COBAS E 801 ANALYTICAL UNIT LINE 2 WAS WITH A SERIAL NUMBER OF (B)(6). THE COBAS E 801 ANALYTICAL UNIT LINE 1 WAS WITH A SERIAL NUMBER OF (B)(6). THE COBAS E 801 ANALYTICAL UNIT LINE 3 WAS WITH A SERIAL NUMBER OF (B)(6). THE ALARM TRACE ON 8-JUN-2023 AND ON 9-JUN-2023 SHOWED SEVERAL ALARMS INCLUDING ABNORMAL ASPIRATION ALARMS AND CELL BLANK ALARMS TWICE. QC WAS ACCEPTABLE. CALIBRATION WAS ACCEPTABLE AND SHOWED NO INDICATION FOR AN GENERIC INSTRUMENT ISSUE. INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER ALLEGED DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED FOR TNTHS. PATIENT 10 WAS TESTED ON (B)(6) 2023: INITIAL RESULT: 26.50 NG/L. REPEAT RESULT: 33.30 NG/L. THE INVESTIGATION REVEALED THAT THERE WAS A LAYER OF DUST THROUGHOUT THE ANALYZER. AN EXPERIMENT WAS CONDUCTED AND IT PROVED THAT THE DUST IN THE ENVIRONMENT COULD CAUSE ERRONEOUSLY HIGH RESULTS IN MAGNITUDE TO WHAT HAS BEEN REPORTED FROM THE PATIENT SAMPLES. THE ROOT CAUSE WAS CONSISTENT WITH A PRE-ANALYTICAL HANDLING ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER ALLEGED DISCREPANT RESULTS FOR ADDITIONAL 2 PATIENTS' SAMPLES TESTED FOR TROPONIN T HS. PATIENT 10: ON (B)(6) 2023: INITIAL RESULT: 14.80 NG/L (TESTED ON LINE 2). 1ST RERUN RESULT: 21.40 NG/L (TESTED ON LINE 2). 2ND RERUN RESULT: 20.10 NG/L (TESTED ON LINE 1). PATIENT 11: ON (B)(6) 2023: INITIAL RESULT: 13.50 NG/L (TESTED ON LINE 2). ON 29-JUL-2023: 1ST RERUN RESULT: 8.61 NG/L (TESTED ON LINE 3). 2ND RERUN RESULT: 10.90 NG/L (TESTED ON LINE 1). INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 4 PATIENTS' SERUM/PLASMA SAMPLES TESTED WITH ELECSYS TROPONIN T HS (TNTHS) ASSAY ON A COBAS E801 ANALYTICAL UNIT (LINE 2) WHEN COMPARED TO A DIFFERENT COBAS E801 ANALYTICAL UNIT (LINE 3). PATIENT 1: ON (B)(6)2023; INITIAL RESULT: 12 NG/L (TESTED ON LINE 2) 1ST RERUN RESULT: 3.5 NG/L A NEW SAMPLE WAS COLLECTED AND TESTED: INITIAL RESULT: < 3 NG/L PATIENT 2: ON (B)(6)2023; INITIAL RESULT: 30 NG/L (TESTED ON LINE 2) 1ST RERUN RESULT: 11 NG/L 2ND RERUN RESULT: 10 NG/L 3RD RERUN RESULT: 40.9 NG/L THE QUESTIONABLE RESULTS WERE NOT REPORTED TO THE PATIENT. A NEW SAMPLE WAS COLLECTED AND TESTED: INITIAL RESULT: 8 NG/L PATIENT 3: ON (B)(6)2023; INITIAL RESULT: 8 NG/L (TESTED ON LINE 2) A NEW SAMPLE WAS COLLECTED AND TESTED: INITIAL RESULT: 47.9 NG/L 1ST RERUN RESULT: 4.67 NG/L 2ND RERUN RESULT: 8.16 NG/L A NEW SAMPLE WAS COLLECTED AND TESTED: INITIAL RESULT: 6 NG/L PATIENT 4: ON (B)(6)2023: INITIAL RESULT: 136 NG/L (TESTED ON LINE 2) 1ST RERUN RESULT: 116 NG/L (TESTED ON LINE 2) 2ND RERUN RESULT: 117 NG/L (TESTED ON LINE 3). 3RD RERUN RESULT: 74.80 NG/L (TESTED ON LINE 2) 4TH RERUN RESULT: 6.39 NG/L (TESTED ON LINE 3) 5TH RERUN RESULT: 7.30 NG/L (TESTED ON LINE 2) 6TH RERUN RESULT: 19 NG/L (TESTED ON LINE 3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565591 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA 642405

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown