BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 10004943 · Received April 28, 2020

    Report

    Report Number
    1319808-2020-00021
    Event Type
    Malfunction
    Date Received
    April 28, 2020
    Date of Event
    April 2, 2020
    Report Date
    April 28, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED LOWER THAN EXPECTED VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM NON-VITROS (BIORAD) QUALITY CONTROL (QC) FLUIDS USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-27-7325 ON A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY CAUSE OF THE EVENT IS AN ISSUE RELATED TO THE BIORAD QUALITY CONTROL FLUIDS INVOLVING EITHER PRE-ANALYTICAL SAMPLE MIX-UP OR IMPROPER PRE-ANALYTICAL SAMPLE PREPARATION AND HANDLING. THE LOWER THAN EXPECTED RESULTS OBTAINED ON THE DATE OF THE EVENT WERE BELOW THE ANALYZER MEASURING RANGE. THE RESULTS OBTAINED ON SUBSEQUENT DATES FOLLOWING THE EVENT WERE STILL LOWER THAN EXPECTED BUT WERE ONLY SLIGHTLY OUTSIDE THE LOW END OF THE 2SD RANGE OF THE CUSTOMER¿S BASELINE MEANS. HOWEVER, AN ISSUE RELATED TO THE BIORAD CONTROL FLUIDS COULD NOT BE CONFIRMED AS IT IS UNKNOWN IF THE CUSTOMER USED FRESH VIALS OF THE BIORAD CONTROL FLUIDS ON SUBSEQUENT TESTING DATES FOLLOWING THE EVENT. A VITROS VALP REAGENT PACK ISSUE IS NOT A LIKELY CONTRIBUTING FACTOR OF THE EVENT AS THE SAME PACK WAS USED TO OBTAIN THE RESULTS ON THE DATE OF THE EVENT WHICH WERE OUTSIDE THE ANALYZER REPORTABLE RANGE AS WAS USED TO OBTAIN THE RESULTS ON SUBSEQUENT DATES WHICH WERE ONLY SLIGHTLY OUTSIDE THE LOW END OF THE 2SD RANGE OF THE CUSTOMER¿S BASELINE MEANS. A SUBOPTIMAL CALIBRATION IS A POSSIBLE CAUSE OF THE CUSTOMER¿S RESULTS RUNNING LOW COMPARED TO PEERS. THE QC RESULTS SHIFTED LOW COMPARED TO PEER DATA AFTER THE CALIBRATION EVENT OF 20 MARCH 2020 FOR VITROS VALP REAGENT LOT 2511-27-7325. HOWEVER, A SUBOPTIMAL CALIBRATION WAS NOT LIKELY A CONTRIBUTING FACTOR OF THE EVENT AS THE LOWER THAN EXPECTED RESULTS OBTAINED ON 02 APRIL 2020 WERE OUTSIDE THE ANALYZER MEASURING RANGE. RESULTS ON SUBSEQUENT DATES FOLLOWING THE EVENT USING THE SAME CALIBRATION PARAMETERS WERE LOWER THAN EXPECTED BUT WERE WELL WITHIN THE ANALYZER¿S MEASURING RANGE. HISTORICAL QUALITY CONTROL RESULTS OBTAINED FROM VITROS VALP REAGENT LOT 2511-27-7325 WERE NOT ACCEPTABLE. THEREFORE, AN ISSUE WITH THE VITROS VALP REAGENT LOT 2511-27-7325 COULD NOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. HOWEVER, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS VALP REAGENT LOT 2511-27-7325. A VITROS GENT MARKER PRECISION TEST PERFORMED BY THE CUSTOMER ON THE VITROS 5600 INTEGRATED SYSTEM WAS WITHIN ORTHO ACCEPTABLE GUIDELINES. THE PRECISION TESTING WAS NOT COMPLETED AROUND THE TIME OF THE EVENT, HOWEVER, AN INSTRUMENT ISSUE IS NOT LIKELY A CONTRIBUTING FACTOR OF THE EVENT AS THE CUSTOMER MADE NO INDICATION THAT ANY SERVICE ACTIONS WERE PERFORMED ON THE VITROS 5600 INTEGRATED SYSTEM BETWEEN THE DATE OF THE EVENT AND THE DATE THE PRECISION TESTING WAS PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED LOWER THAN EXPECTED VALPROIC ACID (VALP) RESULTS FROM NON-VITROS (BIORAD) QUALITY CONTROL (QC) FLUIDS USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-27-7325 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 41000 L1, VITROS VALP RESULTS OF <10, <10, <10 AND <10 UG/ML VERSUS. THE EXPECTED RESULT OF 31.04 UG/ML. BIORAD LOT 41000 L3, VITROS VALP RESULTS OF <10, <10, <10 AND <10 UG/ML VERSUS. THE EXPECTED RESULT OF 116.25 UG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE LOWER THAN EXPECTED RESULTS WERE FROM QC FLUIDS AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. HOWEVER, THE INVESTIGATION WAS UNABLE TO CONFIRM THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO).COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471634 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-27-7325

    Patients

    Seq Age Sex Outcome Treatment
    1