BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV

    MDR report key: 2161632 · Received July 14, 2011

    Report

    Report Number
    1415939-2011-00513
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6C37, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L79. (B)(4), NO KNOWN DEVICE PROBLEM. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT WAS SUBMITTED UNDER BRAND NAME ABBOTT ARCHITECT ANTI-HCV. IT WAS DETERMINED THAT THE INVESTIGATION SHOULD BE PERFORMED ON BRAND NAME AXSYM HCV 3.0 REAGENT. REPORT 1415939-2011-00583 WILL BE SUBMITTED TO REFLECT THIS NEW INFORMATION.

    Description of Event or Problem · 1

    THE LABORATORY DIRECTOR REQUESTED INFORMATION REGARDING THE CONTENT OF THE ARCHITECT HCV POSITIVE CONTROL BECAUSE ONE OF THE OPERATORS SPLASHED IT IN ONE OF HER EYES. INFORMATION ABOUT THE INCIDENT (HOW, WHEN, THE CIRCUMSTANCES) WAS REQUESTED. THE RESPONSE RECEIVED WAS THAT THE OPERATOR WASHED HER EYES WITH PLENTY OF WATER. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT ANTI-HCV MZO ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ARCH I2000: LN 8C89-01 SN (B)(4)| ARCH I2000: LN 8C89-01 SN (B)(4)