BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE D-DIMER PANEL

    MDR report key: 6942683 · Received October 11, 2017

    Report

    Report Number
    2027969-2017-00153
    Event Type
    Injury
    Date Received
    October 11, 2017
    Date of Event
    September 12, 2017
    Report Date
    September 13, 2017
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GHH
    UDI-DI
    00893038002326
    PMA / PMN Number
    K042890
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN-HOUSE TESTING WAS PERFORMED WITH RETAINS OF DEVICE LOT W62923B; 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. THE TRIAGE METERPLUS (SN: (B)(4)) ASSOCIATED WITH THE COMPLAINT WAS RETURNED ON 11/29/2017 AND INVESTIGATED ON 12/1/2017; NO ISSUES WERE OBSERVED DURING TESTING AND THE METER PERFORMED AS EXPECTED. 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.

    Additional Manufacturer Narrative · 1

    IN-HOUSE TESTING WAS PERFORMED WITH RETAINS OF DEVICE LOT W62923B; 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE PATIENT ARRIVED AT THE PHYSICIAN'S OFFICE COMPLAINING OF CHEST PAIN. BOTH D-DIMER AND TNI TESTING WAS CONDUCTED ON THE PATIENT. A WHOLE-BLOOD EDTA SAMPLE WAS COLLECTED AT 4:30 PM AND THE TRIAGE D-DIMER PANEL PRODUCED AN ABNORMAL D-DIMER RESULT OF 1030 NG/ML D-DU. THE TNI RESULTS ARE NOT AVAILABLE PER CUSTOMER BUT PRODUCED A NORMAL RESULT. BASED ON THE ABNORMAL D-DIMER RESULT, THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR A CHEST CT. THE CHEST CT SHOWED NO EVIDENCE OF PULMONARY EMBOLISM AND NO EVIDENCE OF ACUTE CARDIO PULMONARY DISEASE. AT THE EMERGENCY ROOM, CONFIRMATORY TESTING WAS CONDUCTED USING THE HEMOSIL SYSTEM AND RESULTED IN A NORMAL D-DIMER VALUE OF 300 NG/ML D-DU. ON (B)(6) 2017, THE SAME WHOLE-BLOOD EDTA SAMPLE WAS TESTED AN ADDITIONAL TWO TIMES AT APPROXIMATELY 1:00 PM. THE TRIAGE D-DIMER PANEL PRODUCED ABNORMAL RESULTS OF 968 NG/ML D-DU AND 825 NG/ML D-DU. THE FACILITY'S NORMAL D-DIMER CUTOFF FOR BOTH THE TRIAGE AND HEMOSIL SYSTEMS WAS REPORTED TO BE 400 NG/ML D-DU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721901 TRIAGE D-DIMER PANEL FIBRIN SPLIT PRODUCTS GHH ALERE SAN DIEGO, INC. 98100 W62923B 00893038002326

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other