BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBACYTE EXPANDED RH NEGATIVE ANTIBODY SCREEN

    MDR report key: 8206178 · Received December 31, 2018

    Report

    Report Number
    3003580203-2018-00007
    Event Type
    Malfunction
    Date Received
    December 31, 2018
    Date of Event
    August 9, 2018
    Report Date
    December 31, 2018
    Manufacturer
    ALBA BIOSCIENCE LIMITED
    Product Code
    KSZ
    UDI-DI
    05060242471377
    PMA / PMN Number
    BL125337/25
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED TO FDA ON 13-AUG-2018 AS A BPDR (NUMBER (B)(4)) UNDER 21CFR600.14 AND IS NOW BEING REPORTED RETROSPECTIVELY AS AN MDR UNDER 21CFR803 TO ADDRESS AN OBSERVATION RECEIVED FROM FDA DURING THE EI DATED 10-SEP-2018. 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 FIELD CORRECTION AND THEREFORE MEETS THE CRITERIA DESCRIBED IN THE FDA GUIDANCE ON MDR FOR MANUFACTURERS. A NOTIFICATION HAS BEEN SENT TO THE AFFECTED END USERS ON 13-AUG-2018 REQUESTING THEM TO DISCARD THE ORIGINAL (I.E. INCORRECT) ANTIGEN PROFILE CONTAINED WITHIN THE SECONDARY PACKAGING OF LOT V198377 AND REPLACE IT WITH A CORRECTED VERSION PROVIDED WITH THE NOTIFICATION. THE SAME NOTIFICATION AND THE CORRECTED ANTIGEN PROFILE ACCOMPANIED ANY PRODUCTS FROM LOT V198377 SUBSEQUENTLY SHIPPED TO END USERS WHO PLACED NEW ORDERS OF THE AFFECTED PRODUCT. THE ASSIGNED FDA RECALL COORDINATOR ((B)(4)) WAS INFORMED OF THE RECALL ACTIVITY ON 13-AUG-2018. BPD ADDITIONAL INFORMATION WAS SUBMITTED ON 07-SEP-2018. TOTAL QUANTITY DISTRIBUTED: 75. TOTAL NUMBER OF CONSIGNEES: 47. THE RECALL RECONCILIATION WAS COMPLETED ON 24-AUG-2018. CONSIGNEES RESPONDED TO THE NOTIFICATION IN WRITING: 44. REMAINING 3 ACKNOWLEDGED VIA TELEPHONE.

    Description of Event or Problem · 1

    THE ANTIGEN PROFILE FOR US LICENSED REAGENT RED BLOOD CELLS ALBACYTE® EXPANDED RH NEGATIVE ANTIBODY SCREEN (PRODUCT CODE Z464U, LOT NUMBER V198377) SUPPLIED TO CUSTOMERS CONTAINED AN ERROR. TWO OF THE DONORS RECORDED ON THE ANTIGEN PROFILE ARE INCORRECT. THE PHENOTYPES OF THE CELLS IN THE ACTUAL PRODUCT ARE VERY SIMILAR AND COMPATIBLE WITH THE REQUIREMENTS OF AN ANTIBODY SCREEN. THE ORIGINAL (I.E. INCORRECT) AND THE CORRECTED ANTIGEN PROFILES ARE ATTACHED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044963 ALBACYTE EXPANDED RH NEGATIVE ANTIBODY SCREEN REAGENT RED BLOOD CELLS KSZ ALBA BIOSCIENCE LIMITED Z464U V198377 05060242471377

    Patients

    Seq Age Sex Outcome Treatment
    1