BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-DIMER 25 TEST KIT

    MDR report key: 2349157 · Received November 21, 2011

    Report

    Report Number
    2027969-2011-02382
    Event Type
    Injury
    Date Received
    November 21, 2011
    Date of Event
    October 26, 2011
    Report Date
    November 21, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GHH
    PMA / PMN Number
    K042890
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SUPPORT RETAIN SAMPLES FROM D-DIMER LOT W48162 WITH POSITIVE CONTROL CALIBRATOR H. PRODUCT SUPPORT OBSERVATIONS FOR D-DIMER RECOVERY FOLLOW: NO FALSE NEGATIVE IN D-DIMER OBSERVED, ALL DATA POINTS WERE WITHIN THE MANUFACTURING 2SD RANGE. NO ERROR CODES OR DEVICE ISSUES WERE OBSERVED. ALL DATA POINTS WITH CAL H WERE WITHIN THE MANUFACTURING 2SD RANGE, WITH A % RECOVERY OF 101% (WITHIN THE MANUFACTURING FINAL RELEASE SPECS). THE CUSTOMER COMPLAINT OF A FALSE NEGATIVE WAS NOT OBSERVED. PRODUCT SUPPORT ALSO OBSERVED A CV OF 83.6, WITHIN MANUFACTURING FINAL RELEASE SPECIFICATIONS. WITHOUT RETURNED SAMPLE PRODUCT SUPPORT IS UNABLE TO VERIFY THE CUSTOMER'S COMPLAINT; PRODUCT SUPPORT CANNOT RULE OR SAMPLE SPECIFIC OR ENVIRONMENTAL FACTORS, OR CUSTOMER TECHNIQUE/PROCEDURES AS A POSSIBLE CAUSE OF THE DISCREPANT RESULTS. CONCLUSION: PRODUCT SUPPORT TESTED D-DIMER LOT W481662 WITH CAL H (POS CTRL). NO FALSE NEGATIVE RESULTS WERE OBSERVED WITH CAL H. NO ERROR CODES OR DEVICE ISSUES WERE OBSERVED. UNABLE TO REPRODUCE CUSTOMER OBSERVATIONS OF FALSE NEGATIVE D-DIMER. NO PRODUCT DEFICIENCY WAS ESTABLISHED. CUSTOMER DID NOT RETURN SAMPLE FOR FURTHER TESTING. WITHOUT SAMPLE PRODUCT SUPPORT CANNOT RULE OR SAMPLE SPECIFIC OR ENVIRONMENTAL FACTORS, OR CUSTOMER TECHNIQUE/PROCEDURES AS A POSSIBLE CAUSE OF THE DISCREPANT RESULTS. AS OF 11/10/2011, THERE ARE 2 COMPLAINTS FOR D-DIMER LOT W48162. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED A FALSE NEGATIVE D-DIMER RESULT ON TRIAGE D-DIMER TEST VS. THE ACL 9000. PATIENT WAS SEEN IN THE ER ON (B)(6) 2011 COMPLAINING OF SHORTNESS OF BREATH AND RECEIVED A 2100 RESULT FOR BNP. THE ANALYZER, METHODOLOGY AND SAMPLE COLLECTION UNKNOWN. THE NEXT DAY, THE PATIENT CAME TO THIS FACILITY ((B)(6) MEDICAL CENTER) AND RECEIVED A <100NG/ML FOR THE TRIAGE D-DIMER TEST. THE SAME DAY, THE PATIENT WAS TRANSPORTED TO ANOTHER MEDICAL FACILITY WHERE THEY RECEIVED A 2300 RESULT FOR D-DIMER. THE ANALYZER USED TO TEST THE 2300 D-DIMER IS THE ACL 9000. PATIENT'S DIAGNOSIS IS UNKNOWN; MEDICATIONS UNKNOWN; PATIENT DISCHARGE UNKNOWN. CUSTOMER WAS UNWILLING TO PROVIDE OTHER LABORATORY FINDINGS FROM THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-DIMER 25 TEST KIT CARDIAC MARKER TEST GHH ALERE SAN DIEGO, INC. 98100 W48162

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization