BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 9995881 · Received April 24, 2020

    Report

    Report Number
    1319808-2020-00016
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    March 31, 2020
    Report Date
    April 24, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM SAMPLES FROM DIFFERENT PATIENTS, AND LOWER AND HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-VITROS (BIORAD) QUALITY CONTROL (QC) FLUIDS USING VITROS CHEMISTRY PRODUCTS VANC REAGENT LOT 2514-41-7814 ON A VITROS 4600 CHEMISTRY SYSTEM. THERE WERE TWO SEPARATE ISSUES THAT TOOK PLACE FOR THIS EVENT: A DEFINITIVE ASSIGNABLE CAUSE FOR THE LOWER THAN EXPECTED PATIENT SAMPLE AND QUALITY CONTROL RESULTS COULD NOT BE DETERMINED. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS VANC REAGENT LOT 2514-41-7814 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR OF THE EVENT. ADDITIONALLY, CONTINUAL TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS VANC REAGENT LOT 2514-41-7814. HOWEVER, A POSSIBLE CAUSE OF THE EVENT IS A VITROS VANC REAGENT PACK ISSUE RELATED TO THE STORAGE CONDITIONS AT THE CUSTOMER SITE. THE REAGENT WAS STORED CLOSE TO THE REFRIGERATOR DOOR AND THE TEMPERATURE OF THE FRIDGE WAS NOT ROUTINELY MONITORED. MULTIPLE PACK ID¿S FROM THE SAME CARTON OF VITROS VANC REAGENT LOT 2514-41-7814 WERE ASSOCIATED WITH LOWER THAN EXPECTED RESULTS. HOWEVER, BECAUSE LOT 2514-41-7814 WAS NO LONGER AVAILABLE FOR FURTHER TROUBLESHOOTING, THIS ISSUE COULD NOT BE CONFIRMED. THE ASSIGNABLE CAUSE OF THE HIGHER THAN EXPECTED QUALITY CONTROL RESULTS IS A SUBOPTIMAL CALIBRATION. THE CALIBRATION PARAMETERS FROM THE (B)(6) 2020 CALIBRATION EVENT WERE ATYPICAL. THE HIGHER THAN EXPECTED RESULTS WERE ALL OBTAINED USING THIS CALIBRATION WHILE ALL THE LOWER THAN EXPECTED RESULTS WERE OBTAINED USING THE CALIBRATION PARAMETERS FROM THE ORIGINAL (B)(6) 2020 CALIBRATION. THE CAUSE OF THE SUBOPTIMAL CALIBRATION IS UNKNOWN. A VITROS GENTAMICIN (GENT) DIAGNOSTIC PRECISION TEST PERFORMED BY THE CUSTOMER ON THE VITROS 4600 CHEMISTRY SYSTEM WAS WITHIN ORTHO ACCEPTABLE GUIDELINES SUGGESTING AN INSTRUMENT ISSUE WAS NOT LIKELY A CONTRIBUTING FACTOR OF THE EVENT. HOWEVER, BECAUSE THE REQUIRED AMOUNT OF RESULTS FOR A MARKER PRECISION TEST WERE NOT OBTAINED, AN ISSUE WITH THE INSTRUMENT THOUGH UNLIKELY, CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT. ADDITIONALLY, AN ALTERNATE LOT OF VITROS VANC REAGENT YIELDED ACCEPTABLE RESULTS ON THE VITROS 4600 CHEMISTRY.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED LOWER THAN EXPECTED VANCOMYCIN (VANC) RESULTS FROM SAMPLES FROM DIFFERENT PATIENTS, AND LOWER AND HIGHER THAN EXPECTED RESULTS FROM NON-VITROS (BIORAD) QUALITY CONTROL (QC) FLUIDS USING VITROS CHEMISTRY PRODUCTS VANC REAGENT LOT 2514-41-7814 ON A VITROS 4600 CHEMISTRY SYSTEM. PATIENT 1 VITROS VANC RESULT OF <5 UG/ML VS AN EXPECTED RESULT OF 30.90 UG/ML, PATIENT 3 VITROS VANC RESULT OF <5 UG/ML VS AN EXPECTED RESULT OF 22.60 UG/ML. BIORAD LOT 15990 L1 VITROS VANC RESULTS OF 41.61, 40.17 AND 41.57 UG/ML VS AN EXPECTED RESULT OF 5.90 UG/ML; BIORAD LOT 15990 L2 VITROS VANC RESULTS OF <5, <5, AND <5 UG/ML VS AN EXPECTED RESULT OF 17.40 UG/ML; BIORAD LOT 15990 L3 VITROS VANC RESULTS OF <5, <5, AND <5 UG/ML VS AN EXPECTED RESULT OF 32.50 UG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. ONE OF THE LOWER THAN EXPECTED PATIENT SAMPLE RESULTS WAS REPORTED OUT OF THE LABORATORY. HOWEVER, NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE RESULT AND A CORRECTED REPORT WAS LATER ISSUED. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF FOUR MDR¿S FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462469 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN-VITRO DIAGNOSTIC LEH ORTHO-CLINICAL DIAGNOSTICS 2514-41-7814

    Patients

    Seq Age Sex Outcome Treatment
    1