BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 3003855 · Received March 14, 2013

    Report

    Report Number
    1415939-2013-00144
    Event Type
    Death
    Date Received
    March 14, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS A RESULT OF THIS ADVERSE EVENT AND THE PHYSICIAN INQUIRY SURROUNDING, THE LABORATORY'S USE OF 0.3 NG/ML AND THE 99TH PERCENTILE CUTOFFS OUR INVESTIGATION APPROACH INCLUDED: A THOROUGH REVIEW OF ARCHITECT STAT TROPONIN-I PRODUCT LABELING, RESULTS RELATED COMPLAINTS AND OTHER ADVERSE EVENTS. AN ARCHITECT STAT TROPONIN-I LABELING REVIEW WAS PERFORMED AND THE FOLLOWING ELEMENTS ARE PRESENT TO ASSIST WITH THE INTERPRETATION OF ASSAY RESULTS: DIAGNOSTIC PURPOSE IS PROVIDED. INSTRUCTIONS STATE THAT THE ASSAY RESULT SHOULD BE USED IN CONJUNCTION WITH OTHER CLINICAL INFORMATION. LABORATORIES SHOULD ESTABLISH THEIR OWN REFERENCE RANGE. SERIAL SAMPLING IS RECOMMENDED TO DETECT THE TEMPORAL RISE AND FALL OF TROPONIN LEVELS. SERIAL NEGATIVE BLOOD DRAWS OVER TIME ARE RECOMMENDED BEFORE PATIENTS ARE CLASSIFIED AS NEGATIVE FOR A HEART ATTACK. THE 99TH PERCENTILE OF 0.028 NG/ML (TOTAL POPULATION) WAS DETERMINED BASED ON GUIDANCE FROM CLINICAL AND LABORATORY STANDARDS INSTITUTE. THE DIAGNOSTIC CUT-OFF OF 0.30 NG/ML WAS ESTABLISHED USING A POPULATION OF KNOWN MYOCARDIAL INFARCTION AND HEALTHY SAMPLES. ADDITIONALLY, A REVIEW OF (B)(4) PATIENT RESULT COMPLAINTS, BASED ON A STATISTICAL SAMPLING PLAN, FOR ARCHITECT STAT TROPONIN-I WAS PERFORMED. IN (B)(4) COMPLAINTS REVIEWED, THE CUSTOMERS REPORTED USING CUT-OFF VALUES APPROPRIATELY AS OUTLINED IN THE PACKAGE INSERT. THE REMAINING (B)(4) COMPLAINTS REVIEWED DID NOT PROVIDE INFORMATION ABOUT CUT-OFF VALUES. A REVIEW OF ADVERSE EVENTS FOR ARCHITECT STAT TROPONIN-I WAS ALSO COMPLETED FOR A PERIOD OF TWO YEARS TO DETERMINE IF THE USE OF THE DIAGNOSTIC CUT-OFF OF 0.30 NG/ML CONTRIBUTED TO ANY ADVERSE EVENT. (B)(4) ADVERSE EVENTS WERE IDENTIFIED. OF THESE, (B)(4) INCLUDED THE CUSTOMER CUT-OFF VALUE, IN (B)(4) CASES THE CUT-OFF VALUE WAS NOT PROVIDED BY THE CUSTOMER. IN THE (B)(4) TICKETS THAT DOCUMENTED A CUT-OFF, NONE REPORTED USING A 0.30 NG/ML CUT-OFF IN ASSOCIATION WITH THE ADVERSE EVENT. THE RESULTS INDICATE THAT CUSTOMERS HAD ESTABLISHED THEIR OWN REFERENCE RANGES AND/OR REPORTED USING A CUT-OFF CONSISTENT WITH THE 99TH PERCENTILE VALUE OF 0.028 NG/ML AS PROVIDED IN THE ARCHITECT STAT TROPONIN-I PACKAGE INSERT. IN CONCLUSION, THE REVIEW OF ARCHITECT STAT TROPONIN-I LABELING IDENTIFIED THAT THE APPROPRIATE INSTRUCTIONS ARE INCLUDED IN THE PACKAGE INSERT TO ASSIST WITH THE INTERPRETATION OF ASSAY RESULTS. ADDITIONALLY, THE REVIEW OF OTHER PATIENT RESULTS COMPLAINTS AND ADVERSE EVENTS FOR TWO YEARS DID NOT IDENTIFY ANY EVENT WHERE CONFUSION ABOUT THE CUT-OFF LEAD TO INAPPROPRIATE INTERPRETATION OF ASSAY RESULTS. THEREFORE, NO PRODUCT DEFICIENCY OR MALFUNCTION WAS IDENTIFIED.

    Description of Event or Problem · 1

    A PATIENT PRESENTED TO A CARDIOLOGIST WITH CHEST PAIN ON (B)(6) 2013. THE PHYSICIAN DID NOT SEND THE PATIENT TO THE HOSPITAL, BUT RATHER A LABORATORY FOR A BLOOD TEST. THE PATIENT WAS TESTED ON ARCHITECT STAT TROPONIN-I (LIST 2K41-28, LOT 26913UN12) WITH A RESULT OF 0.061 NG/ML. THE PHYSICIAN BELIEVES THE ABBOTT TROPONIN RESULT WAS ACCURATE. THE RESULTS WERE REPORTED TO THE CARDIOLOGIST'S OFFICE REFERENCING BOTH A MYOCARDIAL INFARCTION THRESHOLD OF 0.30 NG/ML AND AN ACUTE CORONARY SYNDROME THRESHOLD OF 0.03 NG/ML. THE RESULTS WERE DELIVERED TO THE CARDIOLOGIST'S OFFICE FROM THE LAB "WITHOUT A SENSE OF URGENCY" AND THE CARDIOLOGIST WAS NOT PRESENT WHEN THE RESULTS WERE RECEIVED. THE PATIENT DIED 15 DAYS AFTER THE BLOOD SAMPLE WAS TESTED. NO OTHER INFORMATION IS AVAILABLE REGARDING THE CAUSE OF DEATH. THERE IS NO CORONER'S REPORT OR DEATH CERTIFICATE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107387 ARCHITECT STAT TROPONIN-I MMI ABBOTT LABORATORIES 26913UN12

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death LN 03M74-95, SN (B)(4)| ARCHITECT I2000SR ANALYZER