BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARVIEW SIMPLIFY D-DIMER

    MDR report key: 844305 · Received February 20, 2007

    Report

    Report Number
    8020026-2007-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2007
    Date of Event
    February 3, 2007
    Report Date
    February 20, 2007
    Manufacturer
    AGEN BIOMEDICAL LTD.
    Product Code
    GHH
    PMA / PMN Number
    K993276
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS DISCOVERED BY TESTING RETAINED SAMPLES OF TEST DEVICES FROM BATCH 682-024 TO INVESTIGATE COMPLAINTS. TWO COMPLAINTS HAVE BEEN RECEIVED ABOUT LOTS DISTRIBUTED IN ANOTHER COUNTRIES THAT CONTAIN THE SAME BATCH NUMBER OF POUCHED DEVICES (682-024)AS IN KIT LOT NUMBER PX018A. TESTING COMMENCED IN JANUARY 2007 USING CHARACTERISED PLASMA SAMPLES OF KNOWN D-DIMER CONCENTRATIONS TO TEST RETAINED TEST DEVICES. RETAINED PRODUCT WAS ALSO ASSESSED USING ANOTHER QUALITY CONTROL TEST - AN ANTIGEN TEST - USED DURING PRODUCT RELEASE TESTING. VARIOUS TESTS WERE PERFORMED OVER SEVERAL DAYS TO ASCERTAIN THE DEPTH OF THE PROBLEM. PLASMA SAMPLES USED IN THE ROUTINE QC RELEASE TESTING WERE TESTED ON FOUR OCCASIONS. THE ROUTINE QC RELEASE PANEL CONTAINS PLASMAS WITH A RANGE OF D-DIMER CONCENTRATIONS INCLUDING WEAK SAMPLES CLOSE TO THE CUT-OFF. ALL PLASMA SAMPLES BELOW SHOULD TEST POSITIVE. TESTING CONCLUSION: QUALITY CONTROL RELEASE PANEL TESTING, CHARACTERIZED SAMPLE TESTING AND ANTIGEN TESTING PERFORMED ON RETAINED 682-024 SHOWED A LOSS IN SENSITIVITY COMPARED TO THE SENSITIVITY WHEN THE PRODUCT WAS INITIALLY RELEASED FOR SALE. THIS TESTING INDICATES THAT LOTS IN THE FIELD CONTAINING POUCHES WOULD NOT BE MEETING SPECIFICATION.

    Description of Event or Problem · 1

    CLEARVIEW SIMPLIFY D-DIMER INVITRO DIAGNOSTIC TEST KITS. LABORATORY USER REPORTED NEGATIVE / WEAK RESULTS WITH LOT IN QUESTION COMPARED TO A DIFFERENT LOT OF THE SAME PRODUCT AND COMPARED TO ANOTHER MANUFACTURER'S TEST. MANUFACTURER'S ASSESSMENT OF RETAINED PRODUCT CONFIRMED THE LABORATORY USERS OBSERVATION. PRODUCT IS EXHIBITING A DECREASE IN SENSITIVITY. QUALITATIVE RESULTS MAY BE AFFECTED AROUND THE CUT-OFF OF THE ASSAY. FALSE NEGATIVES ARE POSSIBLE OR LOW-LEVEL D-DIMER SAMPLES, WHICH MAY INCORRECTLY INFLUENCE THE CLINICAL DIAGNOSTIC DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARVIEW SIMPLIFY D-DIMER GHH GHH AGEN BIOMEDICAL LTD. NA PX018A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening