BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-DIMER

    MDR report key: 11677067 · Received April 16, 2021

    Report

    Report Number
    1823260-2021-01156
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 23, 2021
    Report Date
    April 16, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GHH
    PMA / PMN Number
    K062203
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS CAN DIFFER BETWEEN TESTS DUE TO DIFFERENT SPECIFICITY OF THE ANTIBODY USED OR OTHER TEST CHARACTERISTICS. D-DIMER IS NOT A STANDARDIZED ANALYTE AND RESULTS GENERATED USING DIFFERENT D-DIMER ASSAYS ARE NOT NECESSARILY IDENTICAL DUE TO FACTORS SUCH AS (BUT NOT LIMITED TO): REACTIVITY/SPECIFICITY OF DIFFERENT ANTIBODIES. EPITOPE EXPRESSION DURING FIBRIN FORMATION AND DEGRADATION. HETEROGENEITY OF THE FIBRIN DEGRADATION PRODUCTS IN PLASMA. CALIBRATOR MATERIAL. VARIATION IN OPTICAL DETECTION ABILITY BETWEEN DIFFERENT INSTRUMENTS. ASSAY FORMATS (LATEX BEAD SIZE AND REQUIRED WAVELENGTHS). INTERFERENCE BY OTHER ANALYTES (E.G. RHEUMATOID FACTOR (RF), MOUSE MONOCLONAL ANTIBODIES. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THIS EVENT OCCURRED IN (B)(6). UDI NUMBER = (B)(4).

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH D-DI TINA-QUANT D-DIMER GEN. 2 ON A COBAS 6000 C (501) MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THAT SINCE THE PATIENT WAS RECOVERING, WAS STABLE, AND IL6 VALUES DROPPED FROM A PREVIOUS VALUE OF 9.76 (NO UNITS PROVIDED) TO 2.15, IT WAS EXPECTED THAT D-DIMER VALUES WOULD DROP AS WELL. THE FIRST SAMPLE RESULTED IN A D-DIMER VALUE OF 4006 NG/ML WHEN TESTED ON THE C 501 ANALYZER. THE SAMPLE WAS REPEATED ON A VIDAS ANALYZER, RESULTING IN A VALUE OF 278.39 NG/ML. THE SECOND SAMPLE RESULTED IN A D-DIMER VALUE OF 3848 NG/ML WHEN TESTED ON THE C 501 ANALYZER. THE SAMPLE WAS REPEATED ON A VIDAS ANALYZER, RESULTING IN A VALUE OF 284.81. THIS SAMPLE WAS THEN DILUTED 1:5 AND REPEATED ON THE C 501 ANALYZER, RESULTING IN A VALUE OF 7049 NG/ML ON (B)(6) 2021. THE SAMPLE WAS ALSO DILUTED 1:10 AND REPEATED ON THE C 501 ANALYZER, RESULTING IN A VALUE OF 6904 NG/ML ON (B)(6) 2021. THE THIRD SAMPLE RESULTED IN A D-DIMER VALUE OF 3709 NG/ML WHEN TESTED ON THE C 501 ANALYZER ON (B)(6) 2021. WHEN REPEATED ON A VIDAS ANALYZER, THIS SAMPLE RESULTED IN A VALUE OF 346.36 NG/ML. THE SAMPLE WAS ALSO REPEATED ON A HORIBA PENTRA 400 SYSTEM, RESULTING IN A VALUE OF 294 NG/ML. THE SERIAL NUMBER OF THE C 501 ANALYZER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575422 D-DIMER FIBRIN SPLIT PRODUCTS GHH ROCHE DIAGNOSTICS NA 509145

    Patients

    Seq Age Sex Outcome Treatment
    1 CROCIN ("SOS ON FEVER").| DOXY TABLET (ONE TAB AFTER BREAKFAST FOR 5 DAYS).| LUPENOX INJECTION.| PAN (BEFORE BREAKFAST FOR 10 DAYS).| REMDESIVIR INJECTION.| VITAMIN C TABLET (ONE AT 8 A.M., ONE AT 8 P.M.).| ZINC TABLET (ONE AT 8 A.M.).