BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    MDR report key: 7073675 · Received November 30, 2017

    Report

    Report Number
    2024674-2017-00003
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 2, 2017
    Report Date
    November 30, 2017
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE CUSTOMERS COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING OF RETAIN LOT W63262B WITH IN-HOUSE SAMPLES. NO ISSUES WITH TNI RECOVERY OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT W63262B WAS REVIEWED AND FOUND THE LOT MET RELEASE SPECIFICATIONS. NO ISSUES WITH TNI RECOVERY OBSERVED. THE CUSTOMERS COMPLAINT WAS REPLICATED WITH RETURNED PATIENT SAMPLES. OBSERVED RESULTS BELOW THE TRIAGE TNI THRESHOLD WHILE TESTING ON MULTIPLE TRIAGE DEVICE LOT NUMBERS. RETURNED SAMPLE WAS SENT OUT FOR TESTING ON AN ALTERNATE TNI METHOD PLATFORM; TNI RESULTS WERE CONSISTENT WITH TRIAGE TNI RESULTS. ELEVATED TNI RESULTS WERE ONLY OBSERVED ON AN IN-HOUSE BECKMAN ACCESS2 ANALYZER. DUE TO POTENTIAL SAMPLE INTERFERENCE ON THE BECKMAN ANALYZER, HAMA INTERFERENCE TESTING WAS PERFORMED BUT DID NOT SHOW A SIGNIFICANT CHANGE IN TNI RESULTS. ALTHOUGH HAMA INTERFERENCE WAS NOT OBSERVED, ADDITIONAL PATIENT SAMPLE INTERFERENCE CANNOT BE RULED OUT AS CAUSE FOR THE ELEVATED TNI RESULTS ON THE BECKMAN ANALYZER. UNABLE TO DETERMINE THE ROOT CAUSE OF CUSTOMER'S COMPLAINT. TWO OF THREE TNI METHOD PLATFORMS INDICATED THE RETURNED SAMPLES DID NOT CONTAIN TNI ABOVE PRODUCT THRESHOLD LIMITS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. THIS EVENT IS RELATED TO MDR 2024674-2017-00002.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING EVENTS OCCURRING FOR ONE PATIENT: ON (B)(6) 2017: PATIENT WAS RECEIVING DIALYSIS AND ABNORMALLY LOW HEMOGLOBIN WAS OBSERVED (HGB 8.9). PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT (ED) FOR EVALUATION. RAINBOW DRAWS ARE OBTAINED. PATIENT IS TESTED FOR TNI ON (B)(6) 2017. THE RESULTS OF THIS TESTING ARE CAPTURED IN COMPLAINT (B)(4) AND MDR REFERENCE NUMBER 2024674-2017-00002. PATIENT IS ADMITTED FOR GI BLEED AND ANEMIA. PATIENT IS ORDERED A TRANSFUSION. ON (B)(6) 2017. ON 11:41: A TROPONIN I TEST IS ORDERED. PATIENT SAMPLE IS TESTED ON BECKMAN AND RESULTS WITH A TNI OF 10.00NG/ML. REFERENCE RANGE 0.05-0.50NG/ML. RESULT IS ABOVE UPPER PANIC LIMITS. ON 11:57: A BEDSIDE CARDIAC MARKER TEST IS PERFORMED ON THE PATIENT. PATIENT SAMPLE IS TESTED ON TRIAGE CARDIAC LOT W63262B AND TRIAGE METERPRO SERIAL NUMBER: (B)(4). RESULTS ARE: TNI: <0.05NG/ML; REFERENCE RANGE 0.05-0.40NG/ML. CKMB: 1.3NG/ML; REFERENCE RANGE 1.0-8.0NG/ML. MYO: 243NG/ML; REFERENCE RANGE 5-170. MYO RESULT IS ABOVE HIGH NORMAL. CUSTOMER IS CONTACTED FOR ADDITIONAL INFORMATION AND OUTCOME OF THE PATIENT. ANGIOGRAM WAS DONE ON (B)(6) 2017. FINAL INDICATION STATES: NON-STEMI. PATIENT HAS PREVIOUS HISTORY OF HEART PROBLEMS, WITH PREVIOUS STENTS IN PLACE. THE PATIENT IS NOT ALLEGING A RELATIONSHIP BETWEEN THE TRIAGE SYSTEM AND GI BLEED. PATIENT WAS TREATED FOR THE GI BLEED AND ANEMIA. NO TREATMENT/INTERVENTION ADMINISTERED OR WITHHELD BASED ON TRIAGE RESULTS. PATIENT WAS DISCHARGED ON (B)(6) 2017.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING EVENTS OCCURRING FOR ONE PATIENT: ON (B)(6) 2017: PATIENT WAS RECEIVING DIALYSIS AND ABNORMALLY LOW HEMOGLOBIN WAS OBSERVED (HGB 8.9). PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT (ED) FOR EVALUATION. RAINBOW DRAWS ARE OBTAINED. PATIENT IS TESTED FOR TNI ON (B)(6) 2017. THE RESULTS OF THIS TESTING ARE CAPTURED IN COMPLAINT (B)(4). PATIENT IS ADMITTED FOR GI BLEED AND ANEMIA. PATIENT IS ORDERED A TRANSFUSION. ON (B)(6) 2017. 11:41: A TROPONIN I TEST IS ORDERED. PATIENT SAMPLE IS TESTED ON BECKMAN AND RESULTS WITH A TNI OF 10.00 NG/ML. REFERENCE RANGE 0.05-0.50 NG/ML. RESULT IS ABOVE UPPER PANIC LIMITS. 11:57: A BEDSIDE CARDIAC MARKER TEST IS PERFORMED ON THE PATIENT. PATIENT SAMPLE IS TESTED ON TRIAGE CARDIAC LOT W62363B AND TRIAGE METERPRO SERIAL (B)(4). RESULTS ARE: TNI: <0.05 NG/ML; REFERENCE RANGE 0.05-0.40 NG/ML. CKMB: 1.3 NG/ML; REFERENCE RANGE 1.0-8.0 NG/ML. MYO: 243 NG/ML; REFERENCE RANGE 5-170. MYO RESULT IS ABOVE HIGH NORMAL. CUSTOMER IS CONTACTED FOR ADDITIONAL INFORMATION AND OUTCOME OF THE PATIENT. ANGIOGRAM WAS DONE ON (B)(6) 2017. FINAL INDICATION STATES: NON-STEMI. PATIENT HAS PREVIOUS HISTORY OF HEART PROBLEMS, WITH PREVIOUS STENTS IN PLACE. THE PATIENT IS NOT ALLEGING A RELATIONSHIP BETWEEN THE TRIAGE SYSTEM AND GI BLEED. PATIENT WAS TREATED FOR THE GI BLEED AND ANEMIA. NO TREATMENT/INTERVENTION ADMINISTERED OR WITHHELD BASED ON TRIAGE RESULTS. PATIENT WAS DISCHARGED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852108 TRIAGE CARDIAC TRIPLE MARKER PANEL TRIAGE CARDIAC PANEL, PRODUCT CODE: MMI MMI QUIDEL CARDIOVASCULAR INC. 97000HS W63262B

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR TRIAGE METERPRO, PN 55070, SERIAL (B)(4)