BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE D-DIMER PANEL

    MDR report key: 6159947 · Received December 9, 2016

    Report

    Report Number
    2027969-2016-00701
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Report Date
    November 30, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K042890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W62131. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT W62131 WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. FURTHER INVESTIGATION WAS NOT POSSIBLE SINCE THE CUSTOMER DID NOT RETURN ANY SAMPLES FOR TESTING. UNABLE TO DETERMINE A ROOT CAUSE FROM THE AVAILABLE INFORMATION. PRODUCT DEFICIENCY WAS NOT ESTABLISHED.

    Description of Event or Problem · 1

    EVENT OCCURRED IN (B)(6). THE CUSTOMER REPORTED RECEIVING A FALSE NEGATIVE RESULT WITH TRIAGE D-DIMER PANEL FROM LOT W62131RBA. THE CUSTOMER RECEIVED A NEGATIVE RESULT OF <100. THE CUSTOMER TESTED WITH EDTA WHOLE BLOOD. THE OTHER GP OF THE PATIENT SENT A SAMPLE FOR CONFIRMATORY TESTING TO A LAB ON THE SAME DAY AND THEY RECEIVED A POSITIVE RESULT OF 694. THE PATIENT'S SPECIMEN WAS SENT TO THE LAB IN A CITRATE TUBE. THERE WERE NO REPORTED ADVERSE EVENTS RELATED TO THE TRIAGE RESULT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808265 TRIAGE D-DIMER PANEL CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 98100EU W62131RBA

    Patients

    Seq Age Sex Outcome Treatment
    1