BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 12041109 · Received June 22, 2021

    Report

    Report Number
    1319808-2021-00009
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 22, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS VANC QUALITY CONTROL RESULTS WERE OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL FLUID USING VITROS CHEMISTRY PRODUCTS VANC REAGENT LOT 2514-42-8534 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE MAGNITUDE OF BIAS OF THE VITROS VANC RESULTS MEETS POTENTIAL HEALTH AND SAFETY CRITERIA AND THE RESULTS ARE REPORTABLE. THE ASSIGNABLE CAUSE OF THE EVENT IS A REAGENT STORAGE RELATED ISSUE. THE CUSTOMER STATED THAT A POSSIBLE MECHANICAL ISSUE HAD BEEN FOUND FOR THE REFRIGERATOR IN WHICH THEIR VITROS VANC REAGENT SUPPLY IS STORED AND THAT THIS MAY HAVE COMPROMISED THE VITROS VANC REAGENT. ADDITIONALLY, THE LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM TWO REAGENT PACKS THAT HAD BEEN LOADED ONTO THE VITROS XT 7600 SYSTEM DURING THE TIMEFRAME OF THE EVENT AND WHICH HAD NOT PREVIOUSLY BEEN USED TO PROCESS ANY TESTS. A SUBOPTIMAL CALIBRATION WAS ALSO OBTAINED USING ONE OF THESE REAGENT PACKS. HISTORICAL VITROS VANC QC RESULTS OBTAINED PRIOR TO THE EVENT AND FROM ALTERNATE REAGENT PACK IDS WERE WITHIN EXPECTATIONS. THE AFFECTED PACK IDS 1808 AND 1809 WERE FRESH PACKS THAT HAD NOT YET BEEN USED FOR PROCESSING AT THE TIME OF THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS VANC LOT 2514-42-8534. AN ALTERNATE LOT OF VITROS VANC STORED AT THE CUSTOMER SITE ALSO PRODUCED UNACCEPTABLE QC RESULTS INDICATING THAT A VITROS VANC LOT 2514-42-8534 SPECIFIC ISSUE IS NOT LIKELY A CONTRIBUTING FACTOR OF THE EVENT. IN ADDITION, AN INSTRUMENT RELATED ISSUE IS NOT LIKELY A CONTRIBUTOR TO THE EVENT AS SERVICE ACTIONS THAT INCLUDED OPTIMIZATION OF THE MICROTIP PROCESSING AREA PERFORMED BY AN ORTHO FE DID NOT RESOLVE THE ISSUE. THE ISSUE WAS RESOLVED AFTER THE CUSTOMER OBTAINED VITROS VANC LOT 2514-42-8534 REAGENT PACKS FROM A SISTER SITE AND RECALIBRATED USING THESE PACKS. (B)(4)

    Description of Event or Problem · 0

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS VANC QUALITY CONTROL RESULTS WERE OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL FLUID USING VITROS CHEMISTRY PRODUCTS VANC REAGENT LOT 2514-42-8534 ON A VITROS XT 7600 INTEGRATED SYSTEM. MAS LOT CHU21113A (L3) RESULTS OF <5, <5, <5, <5, <5 AND <5 UG/ML VS AN EXPECTED RESULT OF 29.6 UG/ML 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 RESULTS WERE FROM A QC FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. HOWEVER, THE INVESTIGATION WAS UNABLE TO CONFIRM THAT PATIENT SAMPLE RESULTS 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 NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939275 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN-VITRO DIAGNOSTICS LEH ORTHO-CLINICAL DIAGNOSTICS 2514-42-8534

    Patients

    Seq Age Sex Outcome Treatment
    1