BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 12420762 · Received September 3, 2021

    Report

    Report Number
    1823260-2021-02577
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 11, 2021
    Report Date
    November 9, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS USING THE CITRATE APPLICATION FOR THE ASSAY AT THE TIME OF THE EVENT; THE CUSTOMER HAS SINCE SWITCHED TO THE EDTA APPLICATION FOR THE ASSAY. AN ISSUE WITH THE COOLING UNIT OF THE INSTRUMENT WAS IDENTIFIED; THE COOLING UNIT WAS REPLACED. SINCE CHANGING TO THE EDTA APPLICATION OF THE ASSAY AND REPLACING THE COOLING UNIT, THE CUSTOMER HAS HAD NO FURTHER ISSUES. IT WAS NOTED THAT THE CUSTOMER DOES NOT PERFORM DECONTAMINATION OF THE EXTERNAL WATER TANK. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IS NOT HAVING ISSUES WITH ANY OTHER TESTS. THE CUSTOMER REPLACED THE SAMPLE PROBE AND LOADED A NEW D-DIMER REAGENT AND RAN CALIBRATION AND QC WHICH WERE ACCEPTABLE. PRECISION TESTING WAS PERFORMED WITH THE SAMPLE FOR PATIENT 1 (ID 571) WITH THE FOLLOWING RESULTS: 312.07 NG/ML, 287.52 NG/ML, 257.67 NG/ML, 315.87 NG/ML AND 324.38 NG/ML. PRECISION TESTING WITH QC MATERIAL SHOWED ISSUES. HARDWARE CHECKS WERE ACCEPTABLE. THE CUSTOMER CHANGES THE WATER IN THE WATER RESERVOIR BUT DOES NOT PERFORM ANY DECONTAMINATION. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THERE WAS AN ALLEGATION OF DISCREPANT RESULTS FOR 3 PATIENT SAMPLES TESTED FOR D-DIMER ON A COBAS INTEGRA 400 PLUS. ON (B)(6) 2021 PATIENT 1 (ID 571) INITIAL RESULT WAS 544.03 NG/ML. THE REPEAT WAS 166.84 NG/ML. ON (B)(6) 2021 PATIENT 2 (ID 851) INITIAL RESULT WAS 621.10 NG/ML. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 189.21 NG/ML AND 117.40 NG/ML. ON (B)(6) 2021 PATIENT 3 (ID 423) INITIAL RESULT WAS 1094.76 NG/ML. THE SAMPLE WAS REPEATED 3 TIMES WITH RESULTS OF 588.11 NG/ML, 522 78 NG/ML AND 394.76 NG/ML. THE SAMPLE WAS SENT FOR RE-CHECKING AND THE RESULT WAS 470 NG/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE LOWER RESULTS WERE BELIEVED TO BE CORRECT. THE D-DIMER REAGENT LOT NUMBER WAS 538225 WITH AN EXPIRATION DATE OF 30-JUN-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317843 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS I400+ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown