BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS XT 7600 INTEGRATED SYSTEM

    MDR report key: 14049858 · Received April 8, 2022

    Report

    Report Number
    1319681-2022-00020
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 3, 2022
    Report Date
    April 8, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED B-HCG AND TSH RESULTS WERE OBTAINED FROM NON-VITRS (BIORAD) QC FLUIDS WHEN TESTED USING VITROS B-HCG LOT 3295 AND VITROS TSH LOT 6710 ON A VITROS XT7600 INTEGRATED SYSTEM. THE MOST LIKELY CAUSE OF THE EVENT IS AN INSTRUMENT RELATED ISSUE. UNACCEPTABLE VITROS B-HCG AND VITROS TSH RESULTS WERE ISOLATED TO A SINGLE INSTRUMENT AND AN ORTHO FIELD ENGINEER (FE) IDENTIFIED THE SR ASSEMBLY WAS LOOSE AND HAD BEEN LEAKING. PRE-SERVICE PRECISION TESTING INDICATED UNACCEPTABLE INSTRUMENT PERFORMANCE. THE ORTHO FE CLEANED THE PUMP AND REPLACED THE SR TUBING. A LUMINOMETER CALIBRATION WAS PERFORMED AS WELL AS AN IRS CALIBRATION. POST-SERVICE DIAGNOSTIC PRECISION TESTING WAS WITHIN ACCEPTABLE GUIDELINES. (B)(4).

    Description of Event or Problem · 0

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED B-HCG AND TSH RESULTS WERE OBTAINED FROM NON-VITRS (BIORAD) QC FLUIDS WHEN TESTED USING VITROS B-HCG LOT 3295 AND VITROS TSH LOT 6710 ON A VITROS XT7600 INTEGRATED SYSTEM. BIORAD 85270 (LEVEL 1), VITROS B-HCG RESULTS OF 3.15, < 2.39, < 2.39, <2.39 AND <2.39 MIU/ML VERSUS THE PEER MEAN OF 7.96 MIU/ML. BIORAD 85270 (LEVEL 1), VITROS TSH RESULT OF 0.299 AND 0.395 MIU/L VERSUS THE PEER MEAN OF 0.630 MIU/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED VITROS B-HCG AND VITROS TSH RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING NON-PATIENT FLUIDS. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328100 VITROS XT 7600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown