BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-DIMER

    MDR report key: 11542738 · Received March 22, 2021

    Report

    Report Number
    1823260-2021-00884
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    February 20, 2021
    Report Date
    March 22, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GHH
    PMA / PMN Number
    K062203
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6) UNIQUE DEVICE IDENTIFIER (UDI) (B)(4). THE SAMPLES WERE REQUESTED BUT NOT AVAILABLE FOR INVESTIGATION. THE CUSTOMER'S CALIBRATION DATA WAS OK. THE CUSTOMER'S QC DATA CONTAINED RESULTS WITH A HIGH COEFFICIENT OF VARIATION. THE INVESTIGATION REVIEWED THE CUSTOMER'S ALARM TRACE AND NOTICED FREQUENT CELL BLANK ERRORS, WHICH REFLECTED TO POOR SYSTEM MAINTENANCE. THE CUSTOMER'S SAMPLE PRE-ANALYTICAL HANDLING DETAILS WERE REQUESTED BUT NOT PROVIDED. PER PRODUCT LABELING, "HIGH CONCENTRATIONS OF D-FRAGMENTS, AS CAN OCCUR DURING LYSIS THERAPY, LEAD TO DEPRESSED MEASUREMENTS. IN VERY RARE CASES, GAMMOPATHY, IN PARTICULAR TYPE IGM (WALDENSTRÖM¿S MACROGLOBULINEMIA), MAY CAUSE UNRELIABLE RESULTS. IN RARE CASES (LESS THAN 1 REPORTED CASE PER 100000 TESTS) CERTAIN IMMUNOGLOBULINS CAN CAUSE A NON-SPECIFIC AGGLUTINATION LEADING TO FALSELY HIGH RESULT." RESULTS CAN DIFFER BETWEEN TESTS DUE TO THE DIFFERENT SPECIFICITY OF THE ANTIBODY USED OR OTHER TEST CHARACTERISTICS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE D-DIMER RESULTS FOR THREE PATIENTS TESTED ON TWO COBAS 4000 C (311) STAND ALONE SYSTEMS WITH SERIAL NUMBERS (B)(4) AND (B)(4). THE INITIAL D-DIMER RESULTS FROM THE C (311) WITH A SERIAL NUMBER OF (B)(4) WERE REPORTED OUTSIDE THE LABORATORY. THE THERAPIST COMPLAINED TO THE LABORATORY DUE TO THE INITIAL RESULTS NOT MATCHING THE CLINICAL PICTURE OF THE PATIENTS. THE CUSTOMER PERFORMED REPEAT TESTING WITH THE SAMPLES ON A VIDAS ANALYZER, A G10 3500 INSTRUMENT, AND WITH MANUAL LATEX METHODOLOGY FOR CONFIRMATION. ON (B)(6) 2021, PATIENT 1'S C (311) D-DIMER RESULT WAS 1.35 UG/ML WITH SERIAL NUMBERS (B)(4) AND (B)(4) . PATIENT 1'S D-DIMER RESULT ON THE VIDAS ANALYZER WAS 0.43 UG/ML. PATIENT 1'S D-DIMER RESULTS ON THE G10 3500 INSTRUMENT AND WITH MANUAL LATEX METHODOLOGY WERE "NEGATIVE." ON (B)(6) 2021, PATIENT 2'S C (311) D-DIMER RESULT WAS 3.03 UG/ML WITH SERIAL NUMBERS (B)(4) AND (B)(4) . PATIENT 2'S REPEAT RESULT ON THE C (311) SERIAL NUMBER (B)(4) WAS 2.37 UG/ML. PATIENT 2'S D-DIMER RESULT ON THE VIDAS ANALYZER WAS 0.47 UG/ML. PATIENT 2'S D-DIMER RESULTS ON THE G10 3500 INSTRUMENT AND WITH MANUAL LATEX METHODOLOGY WERE "NEGATIVE." ON (B)(6) 2021, PATIENT 3'S INITIAL D-DIMER RESULT ON THE VIDAS ANALYZER WAS "<0.10" MG/L. ON (B)(6) 2021, PATIENT 3'S C (311) D-DIMER RESULT WITH SERIAL NUMBER (B)(4) WAS 1.83 UG/ML WITH A DATA FLAG. ON (B)(6) 2021, THE CUSTOMER PERFORMED DILUTION TESTING WITH THE PATIENT'S SAMPLE ON THE C (311) WITH SERIAL NUMBER (B)(4) . AT 13:55, THE PATIENT'S D-DIMER RESULT WITH "DILUTION BY VOLUME DECREASE" WAS 0.11 UG/ML WITH A DATA FLAG. THE C (311) PERFORMED AN AUTOMATIC RERUN, AND THE PATIENT'S D-DIMER RESULT WAS 1.93 UG/ML. AT 15:51, THE CUSTOMER PERFORMED A 1:2 MANUAL DILUTION AND THE PATIENT'S D-DIMER RESULT WAS 0.60 UG/ML. AT 20:21, THE CUSTOMER PERFORMED A 1:3 MANUAL DILUTION AND THE PATIENT'S D-DIMER RESULT WAS 0.39 UG/ML. PATIENT 3'S D-DIMER RESULTS ON THE G10 3500 INSTRUMENT AND WITH MANUAL LATEX METHODOLOGY WERE "NEGATIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442094 D-DIMER FIBRIN SPLIT PRODUCTS GHH ROCHE DIAGNOSTICS NA 50914501

    Patients

    Seq Age Sex Outcome Treatment
    1