BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB-G

    MDR report key: 10335032 · Received July 28, 2020

    Report

    Report Number
    3002809144-2020-00749
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    July 7, 2020
    Report Date
    September 11, 2020
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOL
    UDI-DI
    00380740011185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE REACTIVE RESULTS FOR SEVEN SAMPLES TESTED WITH THE ARCHITECT HAVAB-G ASSAY INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW AND FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DETERMINED NO RELATED TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LOT(S) AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ARCHITECT HAVAB-G REAGENTS IN THE FIELD WAS REVIEWED USING WORLDWIDE DATA AND DETERMINED THAT THE PERFORMANCE OF THE COMPLAINT LOT(S) IS ACCEPTABLE. PRODUCT LABELING REVIEW DETERMINED THAT THE ISSUE WAS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION, WE HAVE DETERMINED THAT THERE IS NO SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY FOR THE ARCHITECT HAVAB-G REAGENT LOT(S) IDENTIFIED IN THIS COMPLAINT. SECTION D11: CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ORIGINAL: ARCHITECT I2000SR ANALYZER ; CHANGED TO: ARCHITECT I1000SR ANALYZER.

    Additional Manufacturer Narrative · 1

    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 REPORTED FALSE REACTIVE ARCHITECT (B)(6) RESULTS ON MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: < 1.0 S/CO = NONREACTIVE, >= 1.00 S/CO = REACTIVE): PATIENT #1 = 1.05 S/CO (OLD), 0.31 S/CO (NEW); PATIENT #2 = 1.09 S/CO (OLD), 0.62 S/CO (NEW); PATIENT #3 = 1.52 S/CO (OLD), 0.62 S/CO (NEW); PATIENT #4 = 1.19 S/CO (OLD), 0.39 S/CO (NEW); PATIENT #5 = 1.05 S/CO (OLD), 0.30 S/CO (NEW); PATIENT #6 = 1.61 S/CO (OLD), 0.48 S/CO (NEW); PATIENT #7 = 1.56 S/CO (OLD), 0.53 S/CO (NEW). THE INITIAL (B)(6) RESULTS WITH THE OLD LOT ARE REACTIVE, REPEAT RESULTS USING THE NEW LOT ARE NONREACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796632 ARCHITECT HAVAB-G IGG ANTI-HAV LOL ABBOTT GMBH N/A 12026BE00 00380740011185

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I 1000SR ANALYZER,| ARCHITECT I2000SR ANALYZER,| LIST 01L86-01, SERIAL (B)(6)| LIST 01L86-01, SERIAL (B)(6)