BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HCV REAGENT KIT

    MDR report key: 11241289 · Received January 27, 2021

    Report

    Report Number
    3002809144-2021-00063
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    May 5, 2020
    Report Date
    July 1, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PREVIOUS VERSIONS OF THIS REPORT INCLUDED A DATE POPULATED IN D9. THIS DATE WAS ERRONEOUSLY POPULATED INTO D9 AND HAS BEEN REMOVED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS SUBMITTED TO POPULATE FIELDS D8 AND/OR H6 WITH DATA THAT HAD PREVIOUSLY BEEN PROVIDED IN FIELD H10. THERE IS NO CHANGE TO THE CONTENT OF THE DATA.

    Additional Manufacturer Narrative · 0

    SECTION D: LOT NUMBER UPDATED. H6 HEALTH EFFECT IMPACT CODE: F26. COMPONENT CODE: G01003. D8 WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. A REVIEW OF TICKETS WAS PERFORMED FOR REAGENT LOT NUMBER 19571BE00. THE TICKET SEARCH DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THE REAGENT LOT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. A RETAINED REAGENT KIT OF LOT NUMBER 19571BE00 WAS TESTED IN A SPECIFICITY SETUP. NO FALSE REACTIVE RESULTS WERE OBTAINED, INDICATING THAT THE SPECIFICITY PERFORMANCE IS NOT NEGATIVELY IMPACTED. THE SAMPLE IN QUESTION WAS OBTAINED BY ABBOTT AND TESTED AS A PART OF INVESTIGATION. THE TESTING RESULTS FOR THIS SAMPLE ARE AS FOLLOWS: ALINITY I ANTI-HCV REACTIVE, INNO-LIA HCV SCORE NEGATIVE AND MIKROGEN RECOMLINE HCV IGG NEGATIVE. RESULTS OBTAINED BY THE CUSTOMER WERE REPRODUCED BY INHOUSE TESTING OF THE RETURN SAMPLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I ANTI-HCV REAGENT LOT 19571BE00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    SECTION B1 AND B5 ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 04 FEB 2021 TO CLARIFY THAT THE CUSTOMER WAS CONSIDERING THE QUESTIONED RESULTS AS A FALSE REACTIVE ON THE RETEST OF THE SPECIMEN. THEREFORE B1 HAS BEEN UPDATED TO INDICATE THAT THE EVENT IS A PRODUCT PROBLEM AND NOT AN ADVERSE EVENT. SECTION B5 HAS BEEN UPDATED WITH THIS ADDITIONAL INFORMATION. SECTION D4 LOT NUMBER AND EXPIRATION DATE HAVE BEEN UPDATED TO REFLECT THE LOT USED IN GENERATION OF THE FALSE REACTIVE RESULT. H4 HAS ALSO BEEN UPDATED TO REFLECT THE MANUFACTURE DATE OF THE FALSE REACTIVE LOT. H1 HAS BEEN UPDATED TO MATCH THE CONSIDERATION IN B1. H6 PATIENT AND DEVICE CODES HAS BEEN UPDATED TO REFLECT A FALSE POSITIVE RESULT.

    Description of Event or Problem · 0

    UPDATE 05 MAR 2021 ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 04 FEB 2021 TO CLARIFY THAT THE CUSTOMER WAS CONSIDERING THE QUESTIONED RESULTS AS A FALSE REACTIVE ON THE RETEST OF THE SPECIMEN. THE CUSTOMER ALSO INDICATED THE BLOOD DONATION WAS NEGATIVE WITH NAT.

    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 8P06 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P05. MULTIPLE IDENTIFIERS FOR THE SINGLE PATIENT (BLOOD DONOR): 2003100 AND 2009080. NO INFORMATION REGARDING THE BLOOD UNIT RECIPIENT IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER GENERATED A (B)(6) ALINITY I ANTI-HCV RESULT FOR ONE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED: ON (B)(6) 2020 SID 2003100 INITIAL RESULT (B)(6) (NONREACTIVE). ON (B)(6) 2020 SID 2009080 (SAME PATIENT AS SID 2003100) INITIAL RESULT (B)(6) (REACTIVE), REPEATED IN DUPLICATE 0.97 (GRAYZONE) AND (B)(6)(REACTIVE). ON (B)(6) 2020 RETESTED FROM (B)(6) 2020 SID 2003100 SAMPLE, INITIAL RESULT (B)(6) (REACTIVE), REPEATED 0.91 (GRAYZONE). THE (B)(6) RESULT OCCURRED ON A BLOOD DONATION. THE BLOOD UNIT HAS SUBSEQUENTLY BEEN TRANSFUSED INTO ANOTHER PATIENT PRIOR TO IDENTIFICATION OF THE (B)(6) RESULT. NO OTHER INFORMATION REGARDING PATIENT OUTCOME IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137497 ALINITY I ANTI-HCV REAGENT KIT ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS MZO ABBOTT GMBH UNKNOWN

    Patients

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