BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY I HBSAG REAGENT KIT

    MDR report key: 16172196 · Received January 15, 2023

    Report

    Report Number
    3008344661-2023-00026
    Event Type
    Injury
    Date Received
    January 15, 2023
    Date of Event
    December 24, 2022
    Report Date
    January 25, 2023
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOM
    PMA / PMN Number
    LOM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ALINITY I HBSAG, LIST NUMBER 8P08-78, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04P53.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR SPLASHED IN THE EYES WITH THE ALINITY I HBSAG CONTROLS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. 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. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ALINITY I HBSAG CONTROL MATERIAL SAFETY DATA SHEET PROVIDES INFORMATION ON HAZARDS IDENTIFICATION, EXPOSURE CONTROLS/PERSONAL PROTECTION AND FIRST AID MEASURES. BASED ON THE REVIEW OF THE ISSUE, THIS REPRESENTS A USE ERROR SINCE THE OPERATOR WAS NOT WEARING PROTECTIVE EYEWEAR. BASED ON THE INVESTIGATION, THE ALINITY I HBSAG CONTROL LOT NUMBER 32057FN01 IN USE WITH THE ALINITY I HBSAG REAGENT LOT NUMBER 43168FN00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER WAS SPLASHED IN THE EYES WITH THE ALINITY I HBSAG CONTROLS WHILE PREPARING TO RUN CONTROLS ON THE ALINITY I PROCESSING MODULE. THE CUSTOMER IMMEDIATELY RINSED THE EYES WITH SALINE AND WAS GIVEN IMMUNOGLOBIN INJECTION. THE CUSTOMER WAS WEARING LAB COAT AND GLOVES HOWEVER, NO EYE PROTECTION WAS WORN. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172866 ALINITY I HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND 43168FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention ALIN I HBSAG CTL (CN), 08P08-19, 32057FN01| ALIN I HBSAG CTL (CN), 08P08-19, 32057FN01| ALNTY I PROCESSING MODU, 03R65-01, AI23455| ALNTY I PROCESSING MODU, 03R65-01, AI23455