BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT

    MDR report key: 4012541 · Received August 15, 2014

    Report

    Report Number
    3007111389-2014-00180
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    July 16, 2014
    Report Date
    August 15, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDES THAT (B)(6) RESULTS WERE OBTAINED FROM A SINGLE BIORAD VIROTROL REACTIVE QUALITY CONTROL FLUID USING THREE DIFFERENT VITROS AHCV LOT 9090 REAGENT PACKS ON TWO DIFFERENT VITROS ECIQ IMMUNODIAGNOSTIC SYSTEMS AND A SINGLE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE ASSIGNABLE CAUSE FOR THE EVENT IS THE VITROS AHCV LOT 9090 REAGENT PACKS IN USE. MULTIPLE VITROS AHCV LOT 9090 REAGENT PACKS IN USE AT MULTIPLE SITES ARE PRODUCING LOWER THAN EXPECTED RESULTS. THE ASSIGNABLE CAUSE AFFECTING THE LOT 9090 REAGENT PACKS IS UNKNOWN. THE INVESTIGATION IS ONGOING. THERE WAS NO INDICATION THE VITROS INSTRUMENTS CONTRIBUTED TO THE EVENT. THE FDA¿S (B)(4) DISTRICT OFFICE WAS NOTIFIED OF THIS ISSUE ON (B)(4) 2014. PLEASE REFER TO REPORT # 3007111389-08/13/2014-001-C.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED MULTIPLE (B)(6) RESULTS OBTAINED FROM A SINGLE NON-VITROS BIORAD VIROTROL REACTIVE CONTROL SAMPLE USING THREE DIFFERENT VITROS AHCV LOT 9090 REAGENT PACKS (PACK 1510, PACK 1543, UNIDENTIFIED PACK) ON TWO DIFFERENT VITROS ECIQ IMMUNODIAGNOSTIC SYSTEMS AND A SINGLE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. PACK 1510: 0.84, 0.82, 0.89 S/C VS. THE EXPECTED RESULT OF >/ = (B)(6). PACK 1543: 0.73 S/C VS. THE EXPECTED RESULT OF >/ = (B)(6). UNIDENTIFIED PACK: 0.88 S/C VS. THE EXPECTED RESULT OF >/ =(B)(6). THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES, HOWEVER; THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS HAD NOT BEEN AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO ALLEGATIONS OF HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDR¿S FOR THIS EVENT. THREE (3) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS 3 DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491258 VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT IN-VITRO DIAGNOSTIC MZO ORTHO-CLINICAL DIAGNOSTICS 9090

    Patients

    Seq Age Sex Outcome Treatment
    1