BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXC 600 PRO

    MDR report key: 17608371 · Received August 23, 2023

    Report

    Report Number
    2050012-2023-00159
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    August 3, 2023
    Report Date
    August 23, 2023
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    15099590310769
    PMA / PMN Number
    K103842
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OF HARM TO THE PATIENT ATTRIBUTABLE TO THE OUTPUT FROM THE DEVICE IN THIS EVENT. THE PATIENT'S ORTHOPEDIC SURGERY WAS RESCHEDULED FOR A LATER TIME. BECKMAN COULTER CUSTOMER TECHNICAL SPECIALIST (CTS) EVALUATED THE ISSUE AND OBSERVED THE CALIBRATOR LOT M209670 WAS NOT LOADED AND THE REAGENT BEING USED IS M211358. CTS ADVISED THE CUSTOMER TO LOAD THE CORRESPONDING CALIBRATOR DISK FOR LOT M209670 AND REPEAT CALIBRATION AND QUALITY CONTROL (QC) TESTING. UPON REPEAT CALIBRATION AND QUALITY CONTROL (QC) TESTING, THE ISSUE WAS RESOLVED. SECTION A2, A4, AND A5: INFORMATION NOT PROVIDED BY CUSTOMER. THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE GENERATION OF FALSE HIGH HBA1C3 (HEMOGLOBIN A1C3) PATIENT RESULTS ON THEIR DXC 600 PRO CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER STATED THE PHYSICIAN CANCELLEDL THE PATIENT'S ORTHOPEDIC SURGERY ON THE DAY THE RESULTS WERE REPORTED OUT. THE CUSTOMER STATED THAT THE A1C LEVELS RAN LOWER AT THE SURGERY CENTER. THERE WAS NO REPORT OF HARM TO THE PATIENT AS A RESULT OF THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51689 DXC 600 PRO ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER UNICEL DXC 600 PRO PACKAGED 15099590310769

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown