BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HCV REAGENT KIT

    MDR report key: 17443014 · Received August 2, 2023

    Report

    Report Number
    3002809144-2023-00339
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    December 30, 2022
    Report Date
    October 19, 2023
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MFR # 3002809144-2023-00338-00 SUBMITTED FOR SID (B)(6) THAT GENERATED NONREACTIVE ANTI-HCV RESULT WHEN USING REAGENT LOT 46438BE00. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION G1 CONTACT INFORMATION WAS UPDATED TO REFLECT THE CURRENT CONTACT (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P06 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08P05. THE COMPLAINT INVESTIGATION FOR FALSE NONREACTIVE ALINITY I ANTI-HCV RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY RELATED TRENDS FOR THE PRODUCT FOR THE ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE COMPLAINT ISSUE. ALINITY I ANTI-HCV REAGENT LOT 43481BE00 COULD NOT BE TESTED WITH RETURNED SAMPLE ANALYSIS AND IN-HOUSE SENSITIVITY TESTING SINCE THIS LOT HAS EXPIRED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR ALINITY I ANTI-HCV REAGENT LOT 43481BE00.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY I ANTI-HCV RESULTS FOR A 38-YEAR-OLD ADULT PATIENT THAT IS HIV POSITIVE. SINCE (B)(6) 2022, SEVERAL SAMPLES HAVE BEEN DRAWN AND TESTED FOR ANTI-HCV AND ALL HAVE GENERATED NONREACTIVE RESULTS. HOWEVER, AT THE SAME TIME VIRAL LOAD TESTING AND HCV AG TESTING HAD BEEN RUN AT ANOTHER LAB AND GENERATED POSITIVE RESULTS FOR BOTH TESTS. THE PATIENT HAD UNDERGONE TREATMENT AND OBTAINED AN UNDETECTABLE VIRAL LOAD, AND THE ANTI-HCV SEROLOGY TESTING CONTINUES TO BE NEGATIVE. THE CUSTOMER PROVIDED 2 SIDS FOR THE PATIENT: ON (B)(6) 2022, SID (B)(6) WAS PROCESSED ON THE ALINITY USING REAGENT LOT 43481BE00 AND GENERATED A NONREACTIVE RESULT OF 0.12 S/CO AND A VIRAL LOAD OF 500000 IU/ML. INTERNAL QCS OKAY. ON (B)(6) 2023, SID (B)(6) WAS PROCESSED ON THE ALINITY USING REAGENT LOT 46438BE00 AND GENERATED A NONREACTIVE RESULT OF 0.13 S/CO AND A VIRAL LOAD OF 3976000 UI/ML. INTERNAL QCS WERE OKAY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY I ANTI-HCV RESULTS FOR A 38-YEAR-OLD ADULT PATIENT THAT IS HIV POSITIVE. SINCE (B)(6)2022, SEVERAL SAMPLES HAVE BEEN DRAWN AND TESTED FOR ANTI-HCV AND ALL HAVE GENERATED NONREACTIVE RESULTS. HOWEVER, AT THE SAME TIME VIRAL LOAD TESTING AND HCV AG TESTING HAD BEEN RUN AT ANOTHER LAB AND GENERATED POSITIVE RESULTS FOR BOTH TESTS. THE PATIENT HAD UNDERGONE TREATMENT AND OBTAINED AN UNDETECTABLE VIRAL LOAD, AND THE ANTI-HCV SEROLOGY TESTING CONTINUES TO BE NEGATIVE. THE CUSTOMER PROVIDED 2 SIDS FOR THE PATIENT: ON (B)(6)2022, SID (B)(6)WAS PROCESSED ON THE ALINITY USING REAGENT LOT 43481BE00 AND GENERATED A NONREACTIVE RESULT OF 0.12 S/CO AND A VIRAL LOAD OF 500000 IU/ML. INTERNAL QCS OKAY. ON (B)(6)2023, SID (B)(6)WAS PROCESSED ON THE ALINITY USING REAGENT LOT 46438BE00 AND GENERATED A NONREACTIVE RESULT OF 0.13 S/CO AND A VIRAL LOAD OF 3976000 UI/ML. INTERNAL QCS WERE OKAY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385092 ALINITY I ANTI-HCV REAGENT KIT ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS MZO ABBOTT GMBH 43481BE00

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)