BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL 25T

    MDR report key: 6828989 · Received August 29, 2017

    Report

    Report Number
    2027969-2017-00138
    Event Type
    Malfunction
    Date Received
    August 29, 2017
    Date of Event
    August 22, 2017
    Report Date
    August 22, 2017
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHX
    PMA / PMN Number
    K080269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING WITH RETAINS OF DEVICE LOT W62754B. NO ISSUES WITH CKMB RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR THE LOT WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. THIS EVENT IS BEING REPORTED AS DEVICE IS SAME/SIMILAR TO 510K: K080269.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A NURSE TESTED HER OWN EDTA BLOOD SAMPLE USING THE TRIAGE PROFILER SOB PANEL AND RECEIVED A NORMAL CK-MB RESULT OF <1.0 NG/ML. THE SAMPLE WAS SENT TO THE LABORATORY AND PRODUCED AN ABNORMAL CK-MB RESULT OF 37 U/L. NO TREATMENT OR INTERVENTION WAS ADMINISTERED OR WITHHELD BASED ON THE TRIAGE CK-MB RESULT. FACILITY TRIAGE CK-MB NORMAL CUTOFF= 4.3NG/ML. FACILITY LABORATORY CK-MB NORMAL CUTOFF= 24U/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608619 TRIAGE PROFILER SOB PANEL 25T CARDIOPROFILER PANEL JHX ALERE SAN DIEGO, INC. 97300EU W62754B

    Patients

    Seq Age Sex Outcome Treatment
    1