BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALBAQ-CHEK

    MDR report key: 19770516 · Received July 18, 2024

    Report

    Report Number
    3011683976-2024-00009
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    July 11, 2024
    Report Date
    July 17, 2024
    Manufacturer
    ALBA BIOSCIENCE LIMITED (LTD.)
    Product Code
    QHR
    PMA / PMN Number
    BK170086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT IS NOT RELATED TO THE USE OF THE PRODUCT. OPERATOR GOT INJURED BY A BROKEN VIAL, WHICH BROKES DURING THE CENTRIFUGATION AS PER ROUTINE PROCESS. NO CLINICAL CONSEQUENCES. ALBA BIOSICENCE REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2024, AN OPERATOR WAS INJURED WHEN REMOVING VIAL 2 OF THE QC SET FROM THE CENTRIFUGE. THE TUBE BROKE INJURING THE OPERATOR'S HAND. THE OPERATOR WAS WEARING GLOVES AND DID SEEK MEDICAL ATTENTION, FLUSHING THE WOUND, BANDAGING AND SOUGHT PROPHYLACTIC TREATMENT AGAINST INFECTIOUS DISEASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358738 ALBAQ-CHEK BLOOD GROUPING REAGENT QHR ALBA BIOSCIENCE LIMITED (LTD.) Z498 V274001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention