BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROPONIN T STAT (SHORT TURN AROUND TIME)

    MDR report key: 4844882 · Received June 15, 2015

    Report

    Report Number
    1823260-2015-03630
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 20, 2015
    Report Date
    June 30, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K051752
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THAT THE LOT TO LOT VARIABILITY WITH TNT STAT REAGENT LOT 180705 EXCEEDS THE EXPECTED VALUE. THE INVESTIGATION FOUND LOT 180705 RECOVERED LOWER THAN LOTS 178050 OR 184443. NO SPECIFIC CAUSE FOR THE LOWER RECOVERY WAS FOUND. THERE WAS NO RISK RELATED TO THIS ISSUE AS THERE WAS NO VIOLATION OF THE STANDARDIZATION OR FINAL QUALITY RELEASE SPECIFICATIONS. LOT NUMBER AND EXPIRATION DATE HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 1

    THE DIFFERENCE IN RESULTS BETWEEN TNT STAT LOT 184443 AND TNT LOT 180518 CAN BE ATTRIBUTED TO THE PERFORMANCE SPECIFICATIONS OF THE ASSAY. THE DIFFERENCE SEEN IN THE COMPARED VALUES OF THESE ASSAY LOT NUMBERS IS WITHIN THE ASSAY PERFORMANCE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SHIFT HIGH IN THEIR QUALITY CONTROLS WHEN CHANGING TO TROPONIN T STAT (SHORT TURN AROUND TIME) - TNT STAT REAGENT LOT 18444301 ON (B)(6) 2015. CORRELATION STUDIES WERE THEN PERFORMED WITH 7 PATIENT SAMPLES USING TNT STAT LOT 18444301 AND TROPONIN T (TNT) LOT 18051801 (EXPIRES 11/30/2015). OF THE SEVEN PATIENT SAMPLES, ONE PATIENT SAMPLE HAD DISCREPANT RESULTS. ONLY THE TNT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE RESULTED AS 0.023 NG/ML FOR TNT STAT. WHEN RETESTED USING TNT REAGENT, THE RESULT WAS 0.028. TESTING WAS PERFORMED ON AN E601 MODULE ANALYZER, SERIAL NUMBER (B)(4). ON (B)(6) 2015, TEN ADDITIONAL PATIENT SAMPLES WERE PULLED FOR TESTING WITH TNT STAT LOT 18444301 AND AN OLDER TNT STAT LOT 18070501 (EXPIRES 11/30/2015). OF THESE TEN SAMPLES, ONE SAMPLE HAD ERRONEOUS RESULTS. VALUES OBTAINED WITH THE OLDER TNT STAT LOT WERE BELIEVED TO BE CORRECT. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE PULLED ON (B)(6) 2015 GAVE A RESULT OF 0.016 NG/ML WHEN TESTED WITH LOT 1844301 ON AND E601 MODULE ANALYZER, SERIAL NUMBER (B)(4). THE SAMPLE GAVE A RESULT OF 0.03 NG/ML WITH TNT STAT LOT 18070501 ON (B)(6) 2015. IT IS NOT KNOWN WHICH ANALYZER THIS RESULT WAS OBTAINED FROM. THE PATIENTS WERE NOT ADVERSELY AFFECTED. FOR THE CORRELATION STUDIES PERFORMED, IT IS NOT KNOWN IF ANY OF THE RESULTS WERE USED FOR DIAGNOSTIC PURPOSES. THIS MEDWATCH WILL REFER TO RESULTS OBTAINED ON E601 MODULE SERIAL NUMBER (B)(4). FOR INFORMATION RELATED TO E601 ANALYZER SERIAL NUMBER (B)(4), PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE CUSTOMER DECLINED SERVICE STATING THAT THE COMPARISON THAT WAS PERFORMED LOOKS GOOD. THE CUSTOMER STATED THAT THEY WERE STARTING TO REPORT PATIENTS USING NEW TNT STAT REAGENT LOT NUMBER 18444301 AND THAT THEIR CONTROL RANGES HAVE BEEN ADJUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388753 TROPONIN T STAT (SHORT TURN AROUND TIME) IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA 18070501

    Patients

    Seq Age Sex Outcome Treatment
    1