BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV

    MDR report key: 6052243 · Received October 24, 2016

    Report

    Report Number
    3002809144-2016-00091
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    September 14, 2016
    Report Date
    November 14, 2016
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND ACCURACY TESTING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CAUSED THE CUSTOMER ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. AN INTERNAL PANEL WAS TESTED WITH RETAINED KITS AND ACCURACY TESTING MET ALL SPECIFICATIONS. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS COMPLAINT INVESTIGATION, THE ASSAY PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED (B)(6) RESULTS GENERATED USING THE ARCHITECT (B)(6) REAGENTS. THE FOLLOWING DATA WAS PROVIDED FOR ONE PATIENT (S/CO). SID (B)(6) INITIAL (B)(6), RETEST (B)(6). SAMPLE RETEST USING OTHER METHODS WAS RNA NEGATIVE AND (B)(6), HOWEVER THE SPECIFIC METHOD FOR THE RETEST ANTI-HCV REACTIVE RESULT WAS NOT PROVIDED. SID (B)(6) (REDRAWN SAMPLE) (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702996 ARCHITECT ANTI-HCV ANTI-HCV MZO ABBOTT GERMANY 62280LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000 ANALYZER| LIST NUMBER 03M74-01| SERIAL NUMBER (B)(4)