BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    MDR report key: 6574325 · Received May 17, 2017

    Report

    Report Number
    2027969-2017-00089
    Event Type
    Injury
    Date Received
    May 17, 2017
    Date of Event
    April 18, 2017
    Report Date
    June 1, 2017
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING. THIS EVENT IS BEING REPORTED AS PART NUMBER 97000HSEU IS SAME/SIMILAR TO K030286.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAINED DEVICES FROM LOT W62320RB. NO ISSUES WITH TROPONIN (TNI) RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR THE COMPLAINT LOT WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. THE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE DISTRIBUTOR PROVIDED THE FOLLOWING INFORMATION FOR ALLEGED DISCREPANT TNI RESULTS OCCURRING ON ONE PATIENT: ON THE NIGHT OF (B)(6) 2017, THE PATIENT WAS ADMITTED TO HOSPITAL ONIX AFTER EXPERIENCING CHEST PAIN THROUGHOUT THE WEEK. THE PATIENT WAS REPORTED AS COMING FROM ANOTHER SERVICE (LANAC - PILAR) WITH AN ABNORMAL TROPONIN RESULT ON THE ELECSYS ROCHE. AT 7:28 PM, THE TRIAGE CARDIAC TRIPLE MARKER PANEL PRODUCED A NORMAL TNI RESULT OF 0.13 NG/ML. THE FOLLOWING RESULTS WERE ALSO RECEIVED: CKMB =1.7 NG/ML AND MYO=111 NG/ML. AT 11:08 PM, ANOTHER TRIAGE CARDIAC TRIPLE MARKER PANEL PRODUCED A NORMAL TNI RESULT OF 0.05 NG/ML. THE FOLLOWING RESULTS WERE ALSO RECEIVED: CKMB =1.4 NG/ML AND MYO=168 NG/ML. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION AND GIVEN UNSPECIFIED MEDICATION. ON (B)(6) 2017 AT 4:24 AM, THE PATIENT WAS REPORTED AS EXPERIENCING NO PAIN DUE TO THE ADMINISTERED MEDICATION. ANOTHER TRIAGE CARDIAC TRIPLE MARKER PANEL WAS PERFORMED AND PRODUCED A NORMAL TNI RESULT OF <0.05 NG/ML. THE FOLLOWING RESULTS WERE ALSO RECEIVED: CKMB =<1.0 NG/ML AND MYO=119 NG/ML. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE SAME DAY THE PATIENT RETURNED TO THE HOSPITAL AND WAS ADMITTED. AT 10:39 AM AN ADDITIONAL TRIAGE CARDIAC TRIPLE MARKER PANEL WAS PERFORMED AND PRODUCED A NORMAL TNI RESULT OF <0.05 NG/ML. THE FOLLOWING RESULTS WERE ALSO RECEIVED: CKMB = 2.0 NG/ML AND MYO=121 NG/ML. THE SERUM SAMPLE WAS SENT TO THE LABORATORY AND TESTED USING THE ARCHITECT I4000 - CHEMILUMINESCENCE (STAT HIGH SENSITIVE TROPONIN-I). THE ARCHITECT I4000 PRODUCED AN ABNORMAL TNI RESULT OF 47.90 PG/ML. THE FOLLOWING RESULTS WERE ALSO RECEIVED: CKMB= 1.10 NG/DL AND CPK CREATINE PHOSPHOKINASE (NAC METHOD: N-ACETYL-L-CYSTEINE)= 143.00 U/L. ON (B)(6) 2017, THE PATIENT UNDERWENT A CATHETERIZATION AND A 90% CASE OF ARTERY OCCLUSION WAS DETECTED. ONE CONVENTIONAL STENT WAS PLACED IN THE PROXIMAL THIRD OF ANTERIOR DESCENDING ARTERY WITH PRIMARY SUCCESS. THE FOLLOWING CONCLUSIONS WERE NOTED: - CROWNS WITH IRREGULARITIES. - SUBOCCLUSIVE LESION OF ANTERIOR DESCENDING. - MODERATE CIRCUMFLEX INJURY. - LEFT VENTRICLE WITH PRESERVED SYSTOLIC FUNCTION. ALL OF THE TREATMENT PROVIDED TO THE PATIENT WAS BASED ON THE CONFIRMATORY TESTING AND NOT THE TRIAGE SYSTEM RESULTS. ON (B)(6) 2017, AN ADDITIONAL TEST USING THE ARCHITECT I4000 - CHEMILUMINESCENCE (STAT HIGH SENSITIVE TROPONIN-I) SYSTEM WAS CONDUCTED AND PRODUCED A CKMB RESULT OF 2.50 NG/DL , A CREATININE (KINETIC ALKALINE PICRATE METHOD) RESULT OF 0.90 MG/DL, A UREASE RESULT OF 33.0 MG/DL, AND A CPK CREATINE PHOSPHOKINASE RESULT OF 127.00 U/L. THE FOLLOWING ARE THE NORMAL TRIAGE CARDIAC TRIPLE MARKER PANEL REFERENCE VALUES THAT WERE PROGRAMMED INTO THE TRIAGE METER: TNI= <0.40 NG/ML, CKMB= <4.3 NG/ML, MYO= <107 NG/ML. THE FOLLOWING ARE THE NORMAL ARCHITECT I4000 REFERENCE VALUES FOR MALES <50 YEARS OLD: TNI= <34.2 PG/ML, CKMB= <7.2 NG/ML, CPK CREATINE PHOSPHOKINASE= 30.00 TO 200.00 U/L, CREATININE= 0.72 TO 1.25 MG/DL, UREASE= 19 TO 44 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354536 TRIAGE CARDIAC TRIPLE MARKER PANEL TRIAGE CARDIAC PANEL MMI ALERE SAN DIEGO, INC. 97000HSEU W62320RB

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R