BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV

    MDR report key: 9896800 · Received March 30, 2020

    Report

    Report Number
    3002809144-2020-00234
    Event Type
    Malfunction
    Date Received
    March 30, 2020
    Date of Event
    March 9, 2020
    Report Date
    May 29, 2020
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF TICKETS WAS PERFORMED FOR REAGENT LOT NUMBER ARCHITECT ANTI-HCV LOT NUMBER 09517BE00. THE TICKET SEARCH DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. SPECIFICITY TESTING WAS PERFORMED WITH A RETAINED KIT OF LOT 09517BE00 AND ALL VALUES WERE WELL WITHIN THE PACKAGE INSERT SPECIFICATIONS. FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, REVIEW OF PRODUCT HISTORICAL DATA, DEVICE HISTORY RECORD REVIEW AND A REVIEW OF LABELING. NO FALSE NONREACTIVE RESULTS WERE OBTAINED. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT ANTI-HCV REAGENT, LOT 09517BE00.

    Additional Manufacturer Narrative · 1

    THERE WAS NO FURTHER PATIENT INFORMATION PROVIDED BY THE CUSTOMER. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT ANTI- HCV ON ONE FEMALE AFRICAN PATIENT. THE RESULTS WERE PROVIDED: ON 09MAR2020 SID 8041468 INITIAL NEAT ANTI HCV RESULT=0.05 S/CO(<1.00 S/CO=NONREACTIVE)/ ON 10MAR2020 REPEATED 1:1 DILUTION ANTI-HCV=0.04 S/CO / 1:2 DILUTION ANTI-HCV=0.03 S/CO / 1:5 DILUTION ANTI-HCV=0.02 S/CO / COBAS 6800 PCR=41,000,000 IE/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. PATIENT WAS IN USE OF METHADONE AND DELIVER BABY FEW DAYS BEFORE THE TEST. SOME TESTING HISTORY: HERPES SIMPLEX IGG=POSITIVE, HERPES SIMPLEX IGM=POSITIVE, ANTI-HBS=POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360914 ARCHITECT ANTI-HCV ANTI-HCV MZO ABBOTT GMBH 09517BE00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER.| ARCHITECT I2000SR ANALYZER.| LN 03M74-95, SERIAL (B)(6). | LN 03M74-95, SERIAL (B)(6)