BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-DIMER

    MDR report key: 12911142 · Received December 1, 2021

    Report

    Report Number
    1823260-2021-03549
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 9, 2021
    Report Date
    February 23, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GHH
    PMA / PMN Number
    K062203
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS REQUESTED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE PATIENT WENT TO A LABORATORY RUNNING D-DIMER ON AN H232 INSTRUMENT AND THE RESULT WAS 0.28 UG/ML (280 NG/ML). TWO SAMPLES FROM THE PATIENT WERE SUBMITTED FOR INVESTIGATION AND RUN ON A C501 MODULE WITH REAGENT LOT 528687. THE SAMPLES WERE RUN NORMAL, DECREASED AND MANUALLY DILUTED (1:10 AND 1:20): NORMAL: 8280 NG/ML AND 8131 NG/ML BOTH WITH > PROZ FLAGS. DECREASE: 22492 NG/ML AND 22185 NG/ML BOTH WITH > TEST FLAGS. 1:10: 10799 NG/ML AND 11342 NG/ML BOTH WITH > TEST FLAGS. 1:20: 111260 NG/ML AND 129600 NG/ML. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE TWO SAMPLES WERE INVESTIGATED FURTHER. THE INVESTIGATION DETERMINED THE HIGH D-DIMER RESULTS WERE CONSISTENT WITH A NON-SPECIFIC REACTION WITH THE IMMUNOGLOBULIN A (IGA) COMPONENT OF THE REAGENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR D-DIMER ON A COBAS 6000 C (501) MODULE COMPARED TO THE STAGO METHOD. THE INITIAL RESULT FROM THE C501 MODULE WAS 8026 NG/ML WITH A DATA FLAG. THE REPEAT RESULT IN DECREASED MODE WAS 21467 NG/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON THE C501 MODULE USING A 1:20 DILUTION AND THE RESULT WAS 131593 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE PATIENT. THE SAMPLE WAS SENT TO ANOTHER LABORATORY USING THE STAGO METHOD AND THE RESULT WAS 190 NG/ML. THE C501 MODULE SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807406 D-DIMER FIBRIN SPLIT PRODUCTS GHH ROCHE DIAGNOSTICS NA 52868701

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ATECAND