BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-DIMER

    MDR report key: 11737056 · Received April 28, 2021

    Report

    Report Number
    1823260-2021-01269
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 1, 2021
    Report Date
    July 8, 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 · 0

    THE QC DATA SHOWS IMPRECISION. THE ALARM TRACE SHOWS CLOT ALARMS. FURTHER INFORMATION FROM THE CUSTOMER SIDE AND THE SAMPLE MATERIAL WERE REQUESTED BUT NOT PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    DISCREPANT RESULTS FOR TWO MORE SAMPLES RAN ON AN UNKNOWN DATE ARE AS FOLLOWS. SAMPLE 1: THE INTEGRA 400 RESULT WAS 5.4 UG/ML. THE MANUAL METHOD RESULT WAS 0.4 UG/ML. SAMPLE 2: THE INTEGRA 400 RESULT WAS 3.7 UG/ML. THE MANUAL METHOD RESULT WAS 0.6 UG/ML.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS ONGOING. THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE D-DIMER GEN. 2 RESULT FOR ONE PATIENT WITH THE COBAS INTEGRA 400 PLUS SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 2.58 UG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS TESTED IN ANOTHER LAB (METHOD UNKNOWN) WITH A RESULT OF 0.3 UG/ML. ON (B)(6) 2021, THE SAMPLE WAS REPEATED ON THE INTEGRA 400 WITH A RESULT OF 3.86 UG/ML. THE SAMPLE WAS ALSO TESTED IN MORE THAN ONE OTHER LABORATORY, AND ALL RESULTS WERE NORMAL (< 0.5 UG/ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638101 D-DIMER FIBRIN SPLIT PRODUCTS GHH ROCHE DIAGNOSTICS NA 51964501

    Patients

    Seq Age Sex Outcome Treatment
    1