BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY I ANTI-HBC II REAGENT KIT

    MDR report key: 16218894 · Received January 20, 2023

    Report

    Report Number
    3002809144-2023-00046
    Event Type
    Injury
    Date Received
    January 20, 2023
    Date of Event
    November 29, 2022
    Report Date
    February 8, 2023
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOM
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    TRENDING REVIEW DETERMINED NO TREND FOR THE ISSUE FOR THE PRODUCT. HISTORICAL COMPLAINT REVIEW DETERMINED NO TREND IN COMPLAINT ACTIVITY FOR THE LOT NUMBER. DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE COMPLAINT LOT WAS PERFORMED, SHOWING THAT THE LOT GENERATES THE EXPECTED RESULTS. ALL SPECIFICATIONS WERE MET AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED, INDICATING THAT THE SENSITIVITY PERFORMANCE IS NOT NEGATIVELY IMPACTED. IN ADDITION, THE CLINICAL SENSITIVITY WAS EVALUATED BY TESTING TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS ON ONE INSTRUMENT. THE LOTS DETECTED THE SAME BLEEDS AS REACTIVE. BASED ON THESE DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE OF THE LOT IS NOT ADVERSELY AFFECTED. BASED ON THE INVESTIGATION, NO DEFICIENCY WITH ALINITY I ANTI-HBC II REAGENT LOT 40456BE00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT FALSE NONREACTIVE ALINITY I ANTI-HBC II RESULTS WERE GENERATED FOR TWO PATIENT (DONOR) SAMPLES. THE FOLLOWING DATA WAS PROVIDED. PATIENT SID (B)(6). (B)(6) 2022. ALINITY I ANTI-HBC II RESULT: 0.23 S/CO (NONREACTIVE). PATIENT SID (B)(6) (SAME DONOR, DIFFERENT DRAW). (B)(6) 2022. ALINITY I ANTI-HBC II RESULT: 1.13 S/CO (REACTIVE). DUE TO THE DISCREPANCY WITH THE PREVIOUS RESULT, THE CUSTOMER RETESTED FROZEN PLASMA FROM THE DONATION ON (B)(6) 2022 AND A REACTIVE RESULT OF 1.14 S/CO WAS GENERATED. THE CUSTOMER STATED THAT THE DONOR UNIT FROM SID (B)(6) (CONCENTRATED ERYTHROCYTES) WAS TRANSFUSED. THERE WAS NO INFECTIOUS DISEASE TRANSMISSION INFORMATION PROVIDED REGARDING THE RECIPIENT OF THE BLOOD PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005033 ALINITY I ANTI-HBC II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT GMBH 40456BE00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability ALNTY I PROCESSING MODU, 03R65-01, AI02310| ALNTY I PROCESSING MODU, 03R65-01, AI02310