BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBACYTE EXPANDED RH NEGATIVE ANTIBODY SCREEN

    MDR report key: 8159675 · Received December 13, 2018

    Report

    Report Number
    3003580203-2018-00001
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    October 11, 2018
    Report Date
    December 11, 2018
    Manufacturer
    ALBA BIOSCIENCE LIMITED
    Product Code
    KSZ
    UDI-DI
    05060242471377
    PMA / PMN Number
    BL125337/25
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ERROR WITHIN THE ANTIGEN PROFILE IS NOT CONSIDERED CRITICAL TO THE PERFORMANCE OF THE PRODUCT AS THE OTHER TWO CELLS PRESENT WITHIN THE LOT ARE P1 POSITIVE AND ARE STATED AS SUCH. THE RELEVANT REGULATORY GUIDELINES DO NOT STATE A REQUIREMENT FOR THE PRESENCE OF A NEGATIVE P1 CELL THEREFORE COMPLIANCE OF THIS LOT TO CFR.660.33 HAS NOT BEEN COMPROMISED. THE EVENT SUBJECT OF THIS REPORT IS DEEMED TO REPRESENT A DEVICE MALFUNCTION WHICH IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY HOWEVER IT HAS BEEN SUBJECT OF RECALL/FIELD CORRECTION AND THEREFORE MEETS THE REPORTING CRITERIA DESCRIBED IN THE FDA GUIDANCE ON MDR FOR MANUFACTURERS. THE IMPACTED LOT EXPIRED ON OCTOBER 15, 2018. A NOTIFICATION WAS SENT TO THE AFFECTED END USERS ON OCTOBER 18, 2018 REQUESTING THEM TO REVIEW ALL TEST RESULTS GENERATED USING THE IMPACTED LOT. A CORRECTED ANTIGEN PROFILE WAS ALSO PROVIDED. A BPDR WAS SUBMITTED ON OCTOBER 18, 2018 AND THE ASSIGNED FDA RECALL COORDINATOR (LAURA HYERONIMUS) WAS INFORMED ON THE SAME DAY. THE DELAY IN THE SUBMISSION OF THIS MDR IS DUE TO ISSUES ENCOUNTERED DURING THE SET UP OF THE ELECTRONIC SUBMISSION.

    Description of Event or Problem · 1

    THE ANTIGEN PROFILE FOR US LICENSED REAGENT RED BLOOD CELLS, EXPANDED RH NEGATIVE ANTIBODY SCREEN (PRODUCT CODE Z464U, LOT NUMBER V199492) SUPPLIED TO CUSTOMERS CONTAINED AN ERROR. DURING IN-HOUSE TESTING OF THE US LICENSED REAGENT RED BLOOD CELL PRODUCTS EXPANDED RH NEGATIVE ANTIBODY SCREEN (PRODUCT CODE Z464U, LOT NUMBER V199492), ALBA BIOSCIENCE DISCOVERED AN ERROR IN THE ANTIGEN PROFILES FOR THE PANEL. CELL 2 IS STATED AS P1 NEGATIVE WHERE THE CELL HAS BEEN TESTED AND SHOWN TO BE P1 POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998227 ALBACYTE EXPANDED RH NEGATIVE ANTIBODY SCREEN REAGENT RED BLOOD CELLS KSZ ALBA BIOSCIENCE LIMITED Z464U V199492 05060242471377

    Patients

    Seq Age Sex Outcome Treatment
    1