BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-DIMER 25 TEST KIT

    MDR report key: 4596520 · Received March 12, 2015

    Report

    Report Number
    2027969-2015-00183
    Event Type
    Injury
    Date Received
    March 12, 2015
    Date of Event
    February 12, 2015
    Report Date
    February 13, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GHH
    PMA / PMN Number
    K042890
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO DISCREPANT LOW RESULTS WERE OBSERVED WITH ANY DEVICES TESTED WITH CM CALIBRATOR H. DATA RESULTS FROM ALL DEVICES TESTED WERE WITHIN MANUFACTURING FINAL RELEASE SPECIFICATIONS. NO DEVICE ISSUES OR ERROR CODES WERE OBSERVED DURING TESTING. NO SAMPLE WAS RETURNED TO PRODUCT SUPPORT. UNABLE TO RULE OUT SAMPLE SPECIFIC INTERFERENCE AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS. A REVIEW OF MANUFACTURING BATCH RECORDS INDICATED THAT NO DISCREPANT LOW RESULTS WERE OBSERVED DURING MANUFACTURING FINAL RELEASE TESTING. NO PRODUCT DEFICIENCY WAS ESTABLISHED. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT LOW D-DIMER RESULTS. RESULTS AS FOLLOWS: CUSTOMER CALLED TO OBTAIN THE NORMAL/REFERENCE RANGE FOR THE D-DIMER DEVICE. PATIENT PRESENTED WITH LEG PAIN. THE TRIAGE D-DIMER RESULT WAS 211NG/ML. ULTRA SOUND REVEALED A VENOUS LEG CLOT. THE PATIENT IS NOW AN INPATIENT AT A NEARBY HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170395 D-DIMER 25 TEST KIT CARDIAC MARKER TEST GHH ALERE SAN DIEGO, INC. 98100 W59317B

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization