BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY S ANTI-HCV REAGENT KIT

    MDR report key: 11901342 · Received May 28, 2021

    Report

    Report Number
    3002809144-2021-00343
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    April 5, 2021
    Report Date
    July 9, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ALINITY S ANTI-HCV REAGENT LOT 21235BE00 IDENTIFIED NORMAL COMPLAINT ACTIVITY. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. FIELD DATA REVIEW SHOWED THAT THE INITIAL AND REPEAT REACTIVE RATE OBSERVED FOR THE COMPLAINT LOT IN BLOOD BANKS MEETS THE SPECIFICITY PERFORMANCE CLAIM OF THE PACKAGE INSERT. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. THE PERFORMANCE OF THE LIKELY CAUSE LOT WAS INVESTIGATED BY COMPLETING A REVIEW FOR NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES AND DEVIATIONS RELATED TO THE LIKELY CAUSE LOT. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED WITH ALINITY S ANTI-HCV REAGENT LOT 21235BE00.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6P04-55 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6P04-60. PATIENT IDENTIFIER SIDS: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INCREASE IN REACTIVE RATE FOR THE ALINITY S ANTI-HCV ASSAY FOR THE MONTH OF (B)(6) 2021. PACKAGE INSERT SPECIFICITY VS CUSTOMER¿S (B)(6) 2021 SPECIFICITY: (B)(6) . EXAMPLE RESULTS PROVIDED FOR (B)(6). ALL REPEAT REACTIVE RESULTS WERE CONFIRMED (B)(6) BY WESTERN BLOT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798109 ALINITY S ANTI-HCV REAGENT KIT HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43) QHM ABBOTT GMBH 21235BE00

    Patients

    Seq Age Sex Outcome Treatment
    1 ALNTY S SYSTEM, 06P16-01, (B)(6)| ALNTY S SYSTEM, 06P16-01, (B)(6)