BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL

    MDR report key: 5605570 · Received April 25, 2016

    Report

    Report Number
    2027969-2016-00239
    Event Type
    Malfunction
    Date Received
    April 25, 2016
    Date of Event
    March 25, 2016
    Report Date
    March 29, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DDR, JHX AND MMI. INVESTIGATION/CONCLUSION: THE CUSTOMER'S COMPLAINT OF DISCREPANT LOW TNI ON LOT W60560 WAS NOT REPLICATED WITH IN-HOUSE CALIBRATOR TESTING. THE LOT MET CARDIAC TNI FINAL RELEASE SPECIFICATIONS. THE RETURNED PATIENT SAMPLE YIELDED TNI RESULTS CLOSE TO THE CUSTOMER'S OBSERVED 0.13 NG/ML WHEN TESTED IN-HOUSE. ACCORDING TO PACKAGE INSERT TRIAGE TNI RANGE, THIS IS AN "ABNORMAL RESULT" AND WOULD PROVIDE THE SAME CLINICAL OUTCOME AS THE LABORATORY RESULTS. BATCH RECORD FOR LOT W60560 WAS REVIEWED AND THE LOT MET ALL CARDIAC HS TNI ONLY FINAL RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED A VARIANCE BETWEEN THE TRIAGE TROPONIN I (TNI) RESULTS AND THE LABORATORY TNI RESULTS. THE PATIENT WAS ADMITTED THROUGH THE EMERGENCY DEPARTMENT. THERE WAS NO DIAGNOSIS PROVIDED. REFERENCE TNI RANGES: TRIAGE 0.0-0.4 / LABORATORY 0.00-0.057. ON (B)(6) 2016 8:05AM: TRIAGE TNI NOT TESTED; LABORATORY TNI=0.68; ON (B)(6) 2016 12:14PM: SAMPLE SENT TO ANOTHER LABORATORY=0.25 (INSTRUMENT UNKNOWN); ON (B)(6) 2016 3:20PM: TRIAGE TNI=0.13 (SAME TUBE) / LABORATORY TNI=0.572; ON (B)(6) 2016 8:20PM: TRIAGE NOT TESTED / DIMENSION=0.558; ON (B)(6) 2016 ~7:00AM: TRIAGE TNI=0.09 (SAME TUBE), LABORATORY TNI NOT TESTED (ANALYZER DOWN). THE CUSTOMER STATED THAT THE PATIENT WAS TREATED FROM THE LABORATORY RESULTS AND NOT THE TRIAGE RESULTS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261830 TRIAGE CARDIAC PANEL CARDIAC MARKER TEST, NBC ALERE SAN DIEGO, INC. 97021HS W60560RB

    Patients

    Seq Age Sex Outcome Treatment
    1 SIEMEN'S DIMENSION LABORATORY ANALYZER