BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    MDR report key: 7073635 · Received November 30, 2017

    Report

    Report Number
    2024674-2017-00002
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 1, 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 W63298B WITH IN-HOUSE SAMPLES. NO ISSUES WITH TNI RECOVERY OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT W63298B 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 2024674-2017-00003.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTING INFORMATION HAS BEEN CORRECTED.

    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). 14:14: PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT (ED) FOR EVALUATION. RAINBOW DRAWS ARE OBTAINED. 15:00: A TROPONIN I TEST IS ORDERED. PATIENT SAMPLE IS TESTED ON BECKMAN AND RESULTS WITH A TNI OF 11.62NG/ML. REFERENCE RANGE 0.05-0.50NG/ML. RESULT IS ABOVE UPPER PANIC LIMITS. 15:13: AN ECG IS PERFORMED ON THE PATIENT. RIGHT BUNDLE BRANCH BLOCK. LEFT AXIS DEVIATION NOTED. Q WAVES ARE PRESENT IN LEADS II, III, AVF. NO ST CHANGES NOTED. CLINICAL IMPRESSION: REVIEWED BY ED PHYSICIAN, ABNORMAL EKG WITHOUT SIGNIFICANT CHANGE. 15:24 A BEDSIDE CARDIAC MARKER TEST IS PERFORMED ON THE PATIENT. PATIENT SAMPLE IS TESTED ON TRIAGE CARDIAC LOT W63298B AND TRIAGE METERPRO SERIAL NUMBER: (B)(4). RESULTS ARE: TNI: <0.05NG/ML; REFERENCE RANGE 0.05-0.40NG/ML. CKMB: 1.8NG/ML; REFERENCE RANGE 1.0-8.0NG/ML. MYO: 232NG/ML; REFERENCE RANGE 5-170. MYO RESULT IS ABOVE HIGH NORMAL. 16:04: PHYSICIAN REVIEWS RESULTS "PATIENT WITH BEDSIDE TROP THAT IS NEG BUT TROPONIN I OF 11. HE HAS NO CHEST PAIN, SOB, AND I SUSPECT POSSIBLE LAB ERROR" 16:14: PATIENT SAMPLE IS RETESTED ON BECKMAN AND RESULTS WITH A TNI OF 9.96NG/ML. RESULT IS ABOVE UPPER PANIC LIMITS. PATIENT IS ADMITTED FOR GI BLEED AND ANEMIA. PATIENT IS ORDERED A TRANSFUSION. 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). AT 14:14: PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT (ED) FOR EVALUATION. RAINBOW DRAWS ARE OBTAINED. AT 15:00: A TROPONIN I TEST IS ORDERED. PATIENT SAMPLE IS TESTED ON BECKMAN AND RESULTS WITH A TNI OF 11.62NG/ML. REFERENCE RANGE 0.05-0.50NG/ML. RESULT IS ABOVE UPPER PANIC LIMITS. AT 15:13: AN ECG IS PERFORMED ON THE PATIENT. RIGHT BUNDLE BRANCH BLOCK. LEFT AXIS DEVIATION NOTED. Q WAVES ARE PRESENT IN LEADS II, III, AVF. NO ST CHANGES NOTED. CLINICAL IMPRESSION: REVIEWED BY ED PHYSICIAN, ABNORMAL EKG WITHOUT SIGNIFICANT CHANGE. AT 15:24 A BEDSIDE CARDIAC MARKER TEST IS PERFORMED ON THE PATIENT. PATIENT SAMPLE IS TESTED ON TRIAGE CARDIAC LOT W62398B AND TRIAGE METERPRO SERIAL NUMBER:(B)(4). RESULTS ARE: TNI: <0.05NG/ML; REFERENCE RANGE 0.05-0.40NG/ML. CKMB: 1.8 NG/ML; REFERENCE RANGE 1.0-8.0NG/ML. MYO: 232 NG/ML; REFERENCE RANGE 5-170. MYO RESULT IS ABOVE HIGH NORMAL. AT 16:04: PHYSICIAN REVIEWS RESULTS "PATIENT WITH BEDSIDE TROP THAT IS NEG BUT TROPONIN I OF 11. HE HAS NO CHEST PAIN, SOB, AND I SUSPECT POSSIBLE LAB ERROR." AT 16:14: PATIENT SAMPLE IS RETESTED ON BECKMAN AND RESULTS WITH A TNI OF 9.96 NG/ML. RESULT IS ABOVE UPPER PANIC LIMITS. PATIENT IS ADMITTED FOR GI BLEED AND ANEMIA. PATIENT IS ORDERED A TRANSFUSION. 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
    849803 TRIAGE CARDIAC TRIPLE MARKER PANEL TRIAGE CARDIAC PANEL, PRODUCT CODE: MMI MMI QUIDEL CARDIOVASCULAR INC. 97000HS W63298B

    Patients

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