BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AU5800 CHEMISTRY ANALYZER

    MDR report key: 10196625 · Received June 25, 2020

    Report

    Report Number
    9680746-2020-00003
    Event Type
    Injury
    Date Received
    June 25, 2020
    Date of Event
    June 2, 2020
    Report Date
    June 25, 2020
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    15099590000332
    PMA / PMN Number
    K070453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER COMPLAINT HANDLING UNIT REVIEWED THE EVENT INVOLVING THE AU5800 CHEMISTRY ANALYZER. THE CUSTOMER STATED THAT THEY MISTAKENLY USED THE LEVEL 1 CALIBRATOR FOR BOTH CALIBRATION SET POINTS, WHICH RESULTED IN A FLAT CALIBRATION CURVE. CONSEQUENTLY, FALSE RESULTS WERE GENERATED. THE CUSTOMER CORRECTLY USED LEVEL 1 AND LEVEL 2 CALIBRATORS TO RESOLVE THE ISSUE. NO FURTHER ISSUES HAVE BEEN REPORTED. PATIENT INFORMATION NOT PROVIDED BY CUSTOMER. INITIAL REPORTER TELEPHONE NUMBER IS (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS CASE (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE GENERATION OF FALSE HIGH D-DIMER PATIENT RESULTS ON THEIR AU5800 CHEMISTRY ANALYZER. THE CUSTOMER REPORTED SIX (6) PATIENTS WERE REFERRED FOR A COMPUTER TOPOGRAPHY (CT) SCAN. THE CT SCANS FOR ALL PATIENTS RETURNED NEGATIVE FOR DEEP-VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE). ALTHOUGH NO INFORMATION HAS BEEN RECEIVED REGARDING THE USE OF A CONTRAST MEDIUM IN THE CT SCANS, IT IS HIGHLY LIKELY THAT CONTRAST MEDIUM WAS USED DUE TO THE ASSESSMENT OF DVT AND PE. NO PATIENTS RECEIVED ANY MEDICATIONS OR ANY OTHER PROCEDURES AFTER THE CT SCANS. THE CUSTOMER DID NOT PROVIDE DATA OR PATIENT DEMOGRAPHICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658881 AU5800 CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER D-DIMER, R1 2 X 12.5 ML, R2 2 X 12.5 ML 2201 15099590000332

    Patients

    Seq Age Sex Outcome Treatment
    1 Other