BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO REAGENT PACK

    MDR report key: 15447606 · Received September 19, 2022

    Report

    Report Number
    3007111389-2022-00089
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    August 5, 2022
    Report Date
    September 19, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED A VITROS HIV COMBO (HIVC) DISCORDANT NEGATIVE RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED WITH VITROS HIVC REAGENT LOT 0710 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WHEN COMPARED TO A WEAK REACTIVE RESULT OBTAINED FROM A NON-VITROS WESTERN BLOT METHOD. THE ASSIGNABLE CAUSE FOR THE EVENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. AN ORTHO MEDICAL SAFETY OFFICER (MSO) WAS CONSULTED TO DETERMINE IF THE VITROS HIVC NEGATIVE RESULT WAS A BELIEVABLE RESULT. THE MSO STATED IT IS ALSO POSSIBLE THE WESTERN BLOT TEST GENERATED A FALSE POSITIVE OR NONSPECIFIC REACTION, AS WESTERN BLOT IS NORMALLY LESS SENSITIVITY THAN HIVC ASSAY, ESPECIALLY SINCE BOTH THE VITROS AND THE ROCHE TESTS GENERATED NEGATIVE RESULTS. HOWEVER, TO BE CONSERVATIVE, THIS EVENT CAN BE CONSIDERED A FALSE NEGATIVE RESULT IN COMPARISON TO THE WESTERN BLOT IN LACK OF ADDITIONAL TEST RESULTS, E.G., NAT. HISTORIC VITROS HIVC QUALITY CONTROL RESULTS USING VITROS HIVC REAGENT LOT 0710 WERE WITHIN EXPECTED RANGES, INDICATING VITROS HIVC LOT 0710 DID NOT LIKELY CONTRIBUTED TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS PRODUCT HIVC REAGENT LOT 0710. THE INVESTIGATION FOUND NO EVIDENCE INDICATING AN INSTRUMENT PERFORMANCE ISSUE CONTRIBUTED TO THE EVENT, HOWEVER, SINCE NO DIAGNOSTIC WITHIN-RUN PRECISION TESTING WAS PERFORMED AND THEREFORE, AN INSTRUMENTED RELATED PERFORMANCE ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. EMAIL ADDRESS FOR CONTACT OFFICE ABOVE IS (B)(6).

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A VITROS HIVC DISCORDANT NEGATIVE RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED WITH VITROS HIVC REAGENT LOT 0710 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WHEN COMPARED TO A WEAK REACTIVE RESULT OBTAINED FROM A NON-VITROS WESTERN BLOT METHOD. PATIENT SAMPLE RESULT OF 0.23 S/C (<0.90 IS NEG) VERSUS A WEAK REACTIVE NON-VITROS WESTERN BLOT METHOD. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE VITROS HIVC DISCORDANT NEGATIVE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428692 VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO REAGENT PACK IN-VITRO DIAGNOSTICS MZF ORTHO-CLINICAL DIAGNOSTICS 0710

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.