BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY S ANTI-HCV REAGENT KIT

    MDR report key: 11934871 · Received June 3, 2021

    Report

    Report Number
    3002809144-2021-00351
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 4, 2021
    Report Date
    June 24, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    UDI-DI
    00380740117191
    PMA / PMN Number
    200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING CLINICAL STUDIES FOR ALINITY S ANTI-HCV II AT THE CUSTOMER SITE, A TOTAL OF 3167 SAMPLES WERE TESTED, 3 OF WHICH GENERATED POTENTIAL FALSE REACTIVE RESULTS WHEN USING ALINITY S ANTI-HCV, LN 6P04, LOT 24178BE00. TICKET SEARCHES DETERMINED NORMAL COMPLAINT ACTIVITY FOR LOT NUMBER 24178BE00. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE PRODUCT RELATED TO THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TO EVALUATE CLINICAL SPECIFICITY OF THE AFFECTED ALINITY S ANTI-HCV REAGENT LOT 24178BE00, 220 PANEL MEMBERS OF HUMAN NEGATIVE POPULATION PANEL TIER 1 WAS TESTED. THE SPECIFICITY PANEL MET SPECIFICATIONS. NO FALSE REACTIVE RESULTS WERE OBTAINED. FURTHER ADDITIONAL REPLICATES OF THE NEGATIVE CONTROL WERE TESTED WHICH ALL MET SPECIFICATIONS. NO MALFUNCTION WAS IDENTIFIED AT CSL PLASMA WITH LOT 24178BE00. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD, THE DEVICES MET PERFORMANCE SPECIFICATIONS AT THE CUSTOMER SITE. BASED ON THE TOTAL NUMBER OF SAMPLES TESTED AT CSL PLASMA WITH LOT 24178BE00 AND THE NUMBER OF REACTIVE SAMPLES AT THE CUSTOMER SITE AS DOCUMENTED IN THE CURRENT COMPLAINT, THE SPECIFICITY (ASSUMING A ZERO PREVALENCE OF HCV INFECTION FOR THE TESTED SAMPLES) IS CALCULATED TO BE 99.91%, EXCEEDING THE PRODUCT REQUIREMENT REGARDING CLINICAL SPECIFICITY FOR THE ALINITY S ANTI-HCV ASSAY. BASED ON THE INVESTIGATION ALINITY S ANTI-HCV REAGENT LOT 24178BE00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT SARS-COV-2 IGG REAGENT WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: SAMPLE ID (B)(6). THIS IS ALL THE PATIENT INFORMATION PROVIDED. 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 DISCREPANT ALINITY S HCV RESULTS WHILE PERFORMING A CLINICAL STUDY FOR THE ALINITY S ANTI-HCV II ASSAY. THE ANTI- HCV II ASSAY WAS ONLY USED FOR CLINICAL STUDY AND NOT FOR PATIENT MANAGEMENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) : HCV ASSAY = (B)(6). HCV II ASSAY (UNAPPROVED ASSAY) = (B)(6) . POOLED NAT = (B)(6) . ID NAT = (B)(6) . ROCHE ANTI-HCV = (B)(6) . SAMPLE ID (B)(6): HCV ASSAY = (B)(6) . HCV II ASSAY (UNAPPROVED ASSAY) = (B)(6) . POOLED NAT = (B)(6) . ID NAT = (B)(6) . ROCHE ANTI-HCV =(B)(6) . SAMPLE ID (B)(6) : HCV ASSAY = (B)(6) HCV II ASSAY (UNAPPROVED ASSAY) = (B)(6) . POOLED NAT = (B)(6) . ID NAT = (B)(6) . ROCHE ANTI-HCV = (B)(6) . THE REACTIVE ALINITY S ANTI-HCV RESULTS DO NOT MATCH THE POOLED NAT, ID NAT, AND ROCHE (B)(6) RESULTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828252 ALINITY S ANTI-HCV REAGENT KIT HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43) QHM ABBOTT GMBH 24178BE00 00380740117191

    Patients

    Seq Age Sex Outcome Treatment
    1 ALNTY S SYSTEM, 06P16-01, AS1289| ALNTY S SYSTEM, 06P16-01, AS1289