BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE D-DIMER PANEL

    MDR report key: 6946998 · Received October 12, 2017

    Report

    Report Number
    2027969-2017-00155
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    September 21, 2017
    Report Date
    September 26, 2017
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GHH
    PMA / PMN Number
    K042890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: IN-HOUSE TESTING WAS PERFORMED WITH RETAINS OF DEVICE LOT W62926B; HIGHLY ELEVATED D-DIMER RESULTS WERE OBTAINED WITH THE CUSTOMER'S RETURNED SAMPLE. HOWEVER, TESTING WITH WHOLE BLOOD SPECIMENS FROM IN-HOUSE DONORS FOUND NO ISSUES WITH PRODUCT PERFORMANCE. ALL REPLICATES FOR A GIVEN DONOR WERE CONSISTENT WITH ONE ANOTHER AND NO DISCREPANT RESULTS WERE OBSERVED. SAMPLE-SPECIFIC FACTORS IN THE RETURNED SAMPLE CANNOT BE RULED OUT AS THE CAUSE OF THE COMPLAINT. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE PATIENT ARRIVED AT THE FACILITY FEELING POORLY AND EXPERIENCING SHORTNESS OF BREATH AND CHEST PRESSURE. THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT. AT 10:15AM, A WHOLE BLOOD EDTA SAMPLE WAS DRAWN AND AT 11:16AM THE TRIAGE D-DIMER PANEL PRODUCED AN ABNORMAL D-DIMER RESULT OF 1800 NG/ML. THE FOLLOWING DAY, (B)(6) 2017, REPEAT TESTING WAS PERFORMED WITH THE SAME SAMPLE AND AT 11:00AM THE TRIAGE D-DIMER PANEL PRODUCED AN ABNORMAL D-DIMER RESULT OF 1790 NG/ML. DURING THE HOSPITALIZATION, AN EKG WAS PERFORMED DUE TO THE CHEST PAIN AND WAS REPORTED TO BE NEGATIVE. THE FOLLOWING OTHER CARDIAC MARKER RESULTS WERE ALSO RECEIVED DURING THE HOSPITALIZATION: TROPONIN= <0.05 NG/ML AND BNP= 3670 PG/ML (METHOD NOT SPECIFIED). THE DISCHARGE DIAGNOSIS FOR THE PATIENT WAS REPORTED TO BE CHEST PAIN. THE FACILITY'S TRIAGE D-DIMER CUTOFF WAS PROVIDED AS >500 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725011 TRIAGE D-DIMER PANEL FIBRIN SPLIT PRODUCTS GHH ALERE SAN DIEGO, INC. 98100 W62926B

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR