BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE D-DIMER PANEL

    MDR report key: 5212844 · Received November 9, 2015

    Report

    Report Number
    2027969-2015-00914
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 9, 2015
    Report Date
    October 13, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DAP
    PMA / PMN Number
    K042890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: D-DIMER DATA RESULTS FROM ALL LOT W60284B DEVICES TESTED WITH CM CALIBRATOR H WERE WITHIN 2SD OF THE EXPECTED VALUE AND A D-DIMER CV OF 4.76% IS WITHIN FINAL RELEASE TESTING SPECIFICATIONS. REVIEWED THE BATCH RECORD OF LOT W60284B. NO ISSUES WITH D-DIMER RECOVERY OBSERVED. NO NCS OR TIFS WERE GENERATED DURING MANUFACTURING. LOT MET ALL FINAL RELEASE SPECIFICATIONS. NO SAMPLE WAS RETURNED. UNABLE TO RULE OUT SAMPLE SPECIFIC INTERFERENCE AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS. NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    DISCREPANT LOW D-DIMER, EDTA WHOLE BLOOD TESTED X 1, 234 (CUT-OFF 500), PATIENT DIAGNOSED WITH SUBCLAVIAN THROMBOSIS AT ANOTHER FACILITY VIA ULTRASOUND. CUSTOMER STATED PATIENT TESTED FOR D-DIMER WITH EDTA WB SAMPLE, OBTAINED "NEGATIVE" RESULT X 1, 234 NG/ML (CUSTOMER CUT-OFF 0 - 500 NG/ML), DLN W60284. QCD PASSED SUCCESSFULLY ON 10/9, D-DIMER CONTROLS WERE LAST RUN SUCCESSFULLY ON (B)(6) 2015. CUSTOMER STATES PATIENT, (B)(6) MALE WHO WORKS OUTDOORS, CAME INTO EMERGENCY DEPARTMENT WITH ARM INJURY/PAIN/SWELLING. NO OTHER MEDICAL HISTORY OR KNOWN CO-MORBIDITIES. NO KNOWN MEDICATIONS. COMPREHENSIVE METABOLIC PANEL WAS ALSO DRAWN FOR TESTING, ESSENTIALLY NORMAL EXCEPT FOR MILDLY ELEVATED GLUCOSE. PATIENT HAD SLIGHTLY ELEVATED BLOOD PRESSURE, NORMAL TEMPERATURE AND O2 SATURATION. THERE WERE NO CONCERNS ABOUT SAMPLE QUALITY, NO HEMOLYSIS, LIPEMIA OR CLOTS. PATIENT WAS TESTED AND RELEASED WITH A DISCHARGE DIAGNOSIS OF TENDONITIS. PATIENT WENT TO DIFFERENT EMERGENCY DEPARTMENT WHERE HE WAS DIAGNOSED WITH SUBCLAVIAN THROMBOSIS VIA ULTRASOUND. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741124 TRIAGE D-DIMER PANEL CARDIAC MARKER TEST DAP ALERE SAN DIEGO, INC. 98100 W60284B

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR