BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS NA+ SLIDES

    MDR report key: 19136003 · Received April 18, 2024

    Report

    Report Number
    1319809-2024-00041
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    March 19, 2024
    Report Date
    April 17, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JGS
    UDI-DI
    10758750004812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD LIQUICHEK UNASSAYED CONTROL LOT 92970 USING VITROS NA+ SLIDE LOT 4234-1120-5702 TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. AN ISSUE WITH THE BIORAD LEVEL 1 CONTROL FLUID IN USE AT THE TIME OF THE EVENT OR PRE-ANALYTICAL SAMPLE MIX-UP CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. A REVIEW OF THE INDIVIDUAL BIORAD LEVEL 1 RESULTS THAT MET POTENTIAL HEALTH AND SAFETY CRITERIA DETERMINED ACCEPTABLE RESULTS WERE OBTAINED UPON RETEST. ALL REPEAT RESULTS OCCURRED WITHIN 90 MINUTES OF THE INITIAL RESULTS AND EACH INITIAL AND REPEAT RESULT WAS OBTAINED FROM A SLIDE CARTRIDGE IN THE SAME REAGENT SLOT, WHICH INDICATES THE SAME SLIDE CARTRIDGE WAS USED. HOWEVER, THE CUSTOMER DID NOT MAKE ANY COMMENTS CONCERNING THE AFFECTED RESULTS AT THE TIME THE RESULTS WERE GENERATED, SUCH AS WHETHER AN ALTERNATE VIAL OF CONTROLS RESOLVED THE ISSUE OR IF PRE-ANALYTICAL SAMPLE MIX-UP OCCURRED. THEREFORE, IT IS UNKNOWN IF THE EVENTS WERE CAUSED BY THE BIORAD CONTROL FLUIDS IN USE OR IF THE VITROS NA+ SLIDES IN USE MALFUNCTIONED. HOWEVER, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS NA+ SLIDE LOT 4234-1120-5702. THERE IS NO INDICATION THE VTROS 5600 INTEGRATED SYSTEM MALFUNCTIONED, HOWEVER, SINCE THE CUSTOMER DECLINED TO PERFORM DIAGNOSTIC WITHIN-RUN PRECISION TESTING TO ASSESS INSTRUMENT PERFORMANCE, A TRANSIENT PERFORMANCE ISSUE WITH THE VITROS 5600 INTEGRATED SYSTEM CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT. NO INFORMATION CONCERNING FLUID-HANDLING PROTOCOL WAS PROVIDED BY THE CUSTOMER, THEREFORE, IMPROPER FLUID-HANDLING PROTOCOL CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD LIQUICHEK UNASSAYED CONTROL LOT 92970 USING VITROS NA+ SLIDE LOT 4234-1120-5702 TESTED ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 92970 LEVEL 1 VITROS NA+ RESULTS OF 136.2, 140.2 AND 157.9 MMOL/L VS. THE BASELINE MEAN OF 125.8 MMOL/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 HIGHER THAN EXPECTED BIORAD LEVEL 1 NA+ RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL SAMPLES, HOWEVER, THE INVESTIGATION COULD NOT RULE OUT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER 2607238 AND REPORTABILITY ASSESSMENT 605761.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2237544 VITROS CHEMISTRY PRODUCTS NA+ SLIDES IN-VITRO DIAGNOSTICS JGS ORTHO-CLINICAL DIAGNOSTICS, INC. 4234-1120-5702 10758750004812

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown