BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 7759763 · Received August 7, 2018

    Report

    Report Number
    1319681-2018-00077
    Event Type
    Malfunction
    Date Received
    August 7, 2018
    Date of Event
    July 10, 2018
    Report Date
    January 4, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OUR PRELIMINARY INVESTIGATION DETERMINED THAT UNDETECTED VARIABILITY IN THE RELEASE PROCESS CAUSED A NEGATIVE BIAS. WE HAVE IMPLEMENTED INTERIM CORRECTIVE ACTIONS TO HELP PREVENT FUTURE OCCURRENCES. THE FDA¿S NEW YORK DISTRICT OFFICE WAS NOTIFIED OF THIS ISSUE ON 12 DECEMBER 2018. PLEASE REFER TO REPORT#:1319808-12/12/2018-001-C.

    Description of Event or Problem · 0

    THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT BOTH LOWER AND HIGHER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE IS AN INSTRUMENT RELATED EVENT. BASED ON HISTORICAL VITROS VALP QUALITY CONTROL DATA, WITHIN LABORATORY PRECISION WAS ACCEPTABLE PRIOR TO (B)(6) INDICATING VITROS VALP LOT 2511-25-6393 WAS PERFORMING AS EXPECTED. FOLLOWING THE CALIBRATION EVENT ON (B)(6) IN RESPONSE TO AN OBSERVED SHIFT OF QUALITY CONTROL RESULTS, THE WITHIN LABORATORY PRECISION WAS NOT ACCEPTABLE WHEN USING EITHER VITROS VALP LOT 2511-25-6393 OR VITROS VALP LOT 2511-26-6711 BUT WAS ACCEPTABLE AFTER SERVICE ACTIONS WHICH INCLUDED THE REPLACEMENT OF THE MICROIMMUNOASSAY (UIA) PROBOSCIS, THE UIA METERING BELT AND PERFORMING ALL ASSOCIATED ADJUSTMENTS. ALTHOUGH DIAGNOSTIC WITHIN RUN PRECISION TESTING WAS NOT PERFORMED (BEFORE OR AFTER SERVICE) TO EVALUATE THE PERFORMANCE OF THE VITROS 5600 SYSTEM, THE IMPROVED WITHIN LABORATORY PRECISION OBSERVED AFTER SERVICE ACTIONS INDICATE THE VITROS 5600 SYSTEM WAS THE LIKELY CAUSE OF THE IMPRECISE VALP RESULTS.

    Description of Event or Problem · 1

    THE INVESTIGATION DETERMINED THAT LOWER AND HIGHER THAN EXPECTED VITROS VALP RESULTS WERE OBTAINED FROM TESTING NON-VITROS CONTROLS ON A VITROS 5600 INTEGRATED CHEMISTRY SYSTEM USING TWO DIFFERENT LOTS OF VITROS VALP REAGENT. VITROS VALP LOT 2511-25-6393. BIORAD LEVEL 1 CONTROL LOT 47940 VITROS VALP RESULTS 42.8 AND 15.5 UG/ML VERSUS THE EXPECTED VITROS VALP RESULT 26.0 UG/ML. BIORAD LEVEL 2 CONTROL LOT 47940 VITROS VALP RESULTS 45.7 AND 91.5 UG/ML VERSUS THE EXPECTED VITROS VALP RESULT 60.0 UG/ML. BIORAD LEVEL 3 CONTROL LOT 47940 VITROS VALP RESULTS 139.9 AND 80.1 UG/ML VERSUS THE EXPECTED VITROS VALP RESULT 105.0 UG/ML. VITROS VALP LOT 2511-26-6711. BIORAD LEVEL 1 CONTROL LOT 47940 VITROS VALP RESULTS 36.2 AND 37.7UG/ML VERSUS THE EXPECTED VITROS VALP RESULT 26.0 UG/ML. BIORAD LEVEL 2 CONTROL LOT 47940 VITROS VALP RESULTS 84.2 AND 77.8 UG/ML VERSUS THE EXPECTED VITROS VALP RESULT 60.0 UG/ML. BIORAD LEVEL 3 CONTROL LOT 47940 VITROS VALP RESULTS 141.5 AND 127.7 UG/ML VERSUS THE EXPECTED VITROS VALP RESULT 105.0 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THE CUSTOMER STATED THAT NO PATIENT SAMPLES WERE IN QUESTION FOR VITROS VALP OVER THE TIME FRAME OF THE EVENT, HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600286 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1