BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E-ELECSYS TROPONIN I

    MDR report key: 2439804 · Received February 6, 2012

    Report

    Report Number
    1823260-2012-00677
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Date of Event
    January 15, 2012
    Report Date
    April 27, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K082699
    Removal / Correction Number
    Z-1387-2012 AND Z-1388-2
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER INVOLVED IN THIS COMPLAINT, 163175, WAS NOT SOLD IN THE UNITED STATES. THIS EVENT OCCURRED IN (B)(6). LIKE OR SIMILAR LOTS WERE SOLD IN THE UNITED STATES. THE FOLLOWING IS THE OUTCOME OF THIS INVESTIGATION. REDUCED RECOVERY OF LI-HEPARIN PLASMA SAMPLES HAS BEEN CONFIRMED FOR CERTAIN LOTS OF ELECSYS TROPONIN I AND TROPONIN I STAT. IN WORST CASES, LI-HEPARIN SAMPLE RECOVERY MAY BE 50% LOWER THAN SERUM RECOVERY. THIS ISSUE IS CAUSED BY RAW MATERIAL (POLY-L-LYSIN) LOT INSTABILITY. POLY-L-LYSIN IS THE AGENT REQUIRED TO ENSURE CORRECT RECOVERY OF TROPONIN I IN LI-HEPARIN PLASMA SAMPLES. A CHANGE IN REAGENT MANUFACTURING HAS BEEN IMPLEMENTED WITH PRODUCTION OF REAGENT LOTS 164XXX AND HIGHER TO PREVENT THIS ISSUE FROM OCCURRING IN THE FUTURE. A CUSTOMER COMMUNICATION HAS BEEN MAILED TO ALL AFFECTED CUSTOMERS INSTRUCTING IMMEDIATE DISCONTINUATION OF THE USE OF THE AFFECTED LOT NUMBERS AND TO DISCARD THE AFFECTED PRODUCTS FROM INVENTORY ACCORDING TO THE SITE'S LOCAL REGULATIONS. REPLACEMENT KITS WILL BE PROVIDED TO AFFECTED CUSTOMERS. (B)(4).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE TROPONIN I RESULTS FOR TWO SAMPLES FROM ONE PATIENT WHEN THE SAMPLES WERE TESTED WITH DIFFERENT LOT NUMBERS OF THE REAGENT. NO UNITS OF MEASURE WERE PROVIDED. THE RESULT OF THE FIRST SPECIMEN WAS 2.45 WITH REAGENT LOT NUMBER 163175. AS THE PATIENT WAS BEING MONITORED, A SECOND SPECIMEN WAS DRAWN AFTER SIX HOURS. THE RESULT FOR THE SECOND SAMPLE WAS >25 WITH REAGENT LOT NUMBER 164349. AT THE SAME TIME, THEY USED REAGENT LOT NUMBER 163175 TO TEST THE SECOND SPECIMEN, THE RESULT WAS 13.22. THE USER ALSO TESTED THE FIRST SPECIMEN WITH REAGENT LOT NUMBER 164349 AND THE RESULT WAS 8.97. THE USER ALSO TRIED TO USE ANOTHER BOTTLE OF REAGENT LOT NUMBER 164349, BUT THEY STILL GOT A HIGHER RESULT THAN WITH REAGENT LOT NUMBER 163175. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY OR IF THE PATIENT WAS ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E-ELECSYS TROPONIN I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA 163175

    Patients

    Seq Age Sex Outcome Treatment
    1