BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT D-DIMER

    MDR report key: 5093545 · Received September 22, 2015

    Report

    Report Number
    1823260-2015-04201
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    September 2, 2015
    Report Date
    December 15, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GHH
    PMA / PMN Number
    K062203
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION AND IT WAS FOUND A NON-SPECIFIC REACTION FROM IGM COULD HAVE CAUSED THE HIGH D-DIMER RESULT. THE CORRECT D-DIMER RESULT FOR THE SAMPLE WAS THOUGHT TO HAVE BEEN 1.08 UG FEU/ML BASED ON THE CONVERTED VALUES AFTER ABSORPTION WITH ANTI-IGM ANTIBODY. PRODUCT LABELING DOCUMENTS IN RARE CASES, SPECIFIC IMMUNOGLOBULINS, PARTICULARLY IN SAMPLES FROM PATIENTS WITH MYELOMA, CAN GIVE FALSELY HIGH RESULTS.

    Additional Manufacturer Narrative · 1

    THE SAMPLE IN QUESTION WAS SENT TO ANOTHER LABORATORY AND THE RESULTS WERE PROVIDED AS: "INNOVANCE SIEMENS 950 AND 920 TQ ROCH C8000 4740 AND 4770 STAGO STA LIA-DD 1030 AND 990 FDP TEST: 4,6 UG/ML (REF < 5 UG/ML) = NORMAL COMMENT SECOND LAB: "THERE SEEMS TO BE NO HIGH DEGRADATION OF FIBINE, WHICH IS EQUIVALENT TO OUR HYPOTHESIS THAT SOMETHING BOTHERS IN THE DD TEST."

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE D-DIMER RESULTS FOR ONE PATIENT SAMPLE. THE PATIENT WAS KNOWN TO HAVE RESULTS > 7500UG/L SINCE 2010. THE SPECIFIC DATE OF THE EVENT WAS REQUESTED, BUT WAS NOT PROVIDED. THE INITIAL RESULT FROM INTEGRA 400 PLUS ANALYZER SERIAL NUMBER (B)(4) WAS >7500 UG/L WITH A DATA FLAG. THE REPEAT RESULT WAS 18000 UG/L. THE SAME SAMPLE WAS TESTED ON A COBAS6000 ANALYZER AND THE RESULT WAS 7573 UG/L. THE SAMPLE WAS THEN TESTED ON A VIDAS ANALYZER AND THE RESULT WAS 920 UG/L. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED AND WAS DID NOT RECEIVE ANY SPECIAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626989 TINA-QUANT D-DIMER FIBRIN SPLIT PRODUCTS GHH ROCHE DIAGNOSTICS NA 61323101

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR