BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUTE CARE¿ TROPONIN I TESTPAK

    MDR report key: 2041961 · Received April 6, 2011

    Report

    Report Number
    2517506-2011-00063
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 16, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MMI
    PMA / PMN Number
    K051650
    Removal / Correction Number
    2517506-01/07/2011-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT IS UNKNOWN. THE ISSUE IS RELATED TO AN FIELD SAFETY NOTICE BUT THE CUSTOMER DID NOT REPEAT TESTING AS DIRECTED BY THE INSTRUCTIONS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT, INSTRUMENT DATA, AND ROOT CAUSE INVESTIGATION INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT WAS THE GLASS FIBER PAPER LOT USED IN THIS TESTPAK LOT. AN URGENT FIELD SAFETY NOTICE WAS ISSUED IN (B)(6) 2010 AND SENT TO CUSTOMERS WHO HAD ORDERED THIS TESTPAK LOT ADVISING THEM TO REPEAT ALL POSITIVE RESULTS ABOVE 0.07 NG/ML BY AN ALTERNATE METHOD OR TO RUN CCTNI SAMPLES IN DUPLICATE. THE ISSUE IS RELATED TO THIS FIELD SAFETY NOTICE BUT THE CUSTOMER DID NOT REPEAT TESTING AS DIRECTED BY THE INSTRUCTIONS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED TROPONIN I RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. SEQUENTIAL SAMPLES WERE RUN SOON THEREAFTER AND NEGATIVE RESULTS WERE OBTAINED. THE PATIENT WAS ADMITTED. PATIENT TREATMENT WAS NOT REPORTED TO HAVE BEEN OTHERWISE ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULT.

    Description of Event or Problem · 1

    A FALSELY ELEVATED TROPONIN I RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. SEQUENTIAL SAMPLES WERE RUN SOON THEREAFTER AND NEGATIVE RESULTS WERE OBTAINED. THE PATIENT WAS ADMITTED. PATIENT TREATMENT WAS NOT REPORTED TO HAVE BEEN OTHERWISE ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUTE CARE¿ TROPONIN I TESTPAK ACUTE CARE¿ TROPONIN I TESTPAK MMI SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 2303050002

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization