BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY S ANTI-HCV REAGENT KIT

    MDR report key: 11938747 · Received June 4, 2021

    Report

    Report Number
    3002809144-2021-00354
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 4, 2021
    Report Date
    June 21, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    UDI-DI
    00380740117191
    PMA / PMN Number
    200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE REACTIVE ALINITY S ANTI-HCV RESULTS 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 IN-HOUSE TESTING OF RETAINED KITS WITH THE COMPLAINT LOT NUMBER. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT AND COMPLAINT ISSUE. IN-HOUSE SPECIFICITY TESTING OF REAGENT KIT LOT 21239BE00 WAS COMPLETED USING A 220 PANEL MEMBERS OF HUMAN NEGATIVE POPULATION PANEL TIER1. THE SPECIFICITY PANEL MET SPECIFICATIONS. NO FALSE REACTIVE RESULTS WERE OBTAINED. FURTHER ADDITIONAL REPLICATES OF THE NEGATIVE CONTROL WERE TESTED WHICH ALL MET SPECIFICATIONS. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CUSTOMER ISSUE. BASED ON THE TOTAL NUMBER OF SAMPLES TESTED AT BLOODWORKS NORTHWEST WITH LOT 21239BE00 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 21239BE00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY S ANTI-HCV REAGENT WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: SIDS (B)(6). 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 REACTIVE ALINITY S ANTI-HCV RESULTS FOR MULTIPLE SAMPLES COMPARED TO ROCHE ANTI-HCV II ASSAY AND NAT TESTING DURING A COMPARISON STUDY WITH A NEW ABBOTT ANTI-HCV II ASSAY. THE ANTI-HCV RESULTS WERE BEING USED FOR INDIVIDUAL PATIENT MANAGEMENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2021 SID (B)(6) ¿ (B)(6): ANTI-HCV (B)(4) RESULTS = (B)(6). ANTI-HCV II (B)(4) RESULT = (B)(6). NAT POOL OF 6 AND HCV IDT NAT BOTH (B)(6). ROCHE ANTI-HCV II = (B)(6). (B)(6) 2021, SID (B)(6) ¿ (B)(6): ANTI-HCV (B)(4) RESULTS = (B)(6). ANTI-HCV II (B)(4) RESULT = (B)(6). NAT POOL OF 6 AND HCV IDT NAT BOTH (B)(6). ROCHE ANTI-HCV II = (B)(6). (B)(6) 2021, SID (B)(6): ANTI-HCV (B)(4) RESULTS = (B)(6). ANTI-HCV II (B)(4) RESULT = (B)(6). NAT POOL OF 6 IS NEGATIVE AND HCV IDT NAT IS (B)(6). ROCHE ANTI-HCV II = (B)(6). (B)(6) 2021, SID (B)(6): ANTI-HCV (B)(4) RESULTS = (B)(6). ANTI-HCV II (B)(4) RESULTS = (B)(6). NAT POOL OF 6 IS NEGATIVE AND HCV IDT NAT IS (B)(6). ROCHE ANTI-HCV II = REACTIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838120 ALINITY S ANTI-HCV REAGENT KIT HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43) QHM ABBOTT GMBH 21239BE00 00380740117191

    Patients

    Seq Age Sex Outcome Treatment
    1 ALNTY S SYSTEM, 06P16-01, (B)(4)| ALNTY S SYSTEM, 06P16-01, (B)(4)