BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBACYTE ANTIBODY IDENTIFICATION CELLS 16-CELL

    MDR report key: 8206171 · Received December 31, 2018

    Report

    Report Number
    3003580203-2018-00005
    Event Type
    Malfunction
    Date Received
    December 31, 2018
    Date of Event
    May 3, 2018
    Report Date
    December 31, 2018
    Manufacturer
    ALBA BIOSCIENCE LIMITED
    Product Code
    KSZ
    UDI-DI
    05060242471384
    PMA / PMN Number
    BL125337/23
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED TO FDA ON 07-MAY-2018 AS A BPDR (NUMBER (B)(4)) UNDER 21CFR600.14 AND IS NOW BEING REPORTED RETROSPECTIVELY AS A MDR UNDER 21CFR803 TO ADDRESS AN OBSERVATION RECEIVED FROM FDA DURING THE EI DATED 10-SEP-2018. ADDITIONAL DELAY IN THE SUBMISSION OF THIS MDR IS DUE TO ISSUES ENCOUNTERED DURING THE SET UP OF THE ELECTRONIC SUBMISSION. 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. A NOTIFICATION HAS BEEN SENT TO THE AFFECTED END USERS ON 07-MAY-2018 REQUESTING THEM TO DISCARD THE ORIGINAL (I.E. INCORRECT) ANTIGEN PROFILE CONTAINED WITHIN THE SECONDARY PACKAGING OF LOT V194390 AND REPLACE IT WITH A CORRECTED VERSION PROVIDED WITH THE NOTIFICATION. THE SAME NOTIFICATION AND THE CORRECTED ANTIGEN PROFILE ACCOMPANIED ANY PRODUCTS FROM LOT V194390 SUBSEQUENTLY SHIPPED TO END USERS WHO PLACED NEW ORDERS OF THE AFFECTED PRODUCT. THE NOTIFICATION ALSO COVERED THE SAME ISSUE AFFECTING SIMILAR PRODUCTS MANUFACTURED FROM THE SAME STARTING MATERIAL (SUBJECT OF SEPARATE MDRS). THE ASSIGNED FDA RECALL COORDINATOR ((B)(4)) WAS INFORMED OF THE CORRECTION ON 07-MAY-2018 AND BPD ADDITIONAL INFORMATION WAS NOT REQUESTED. TOTAL QUANTITY DISTRIBUTED: (B)(4). TOTAL NUMBER OF CORRECTION CONSIGNEES (COMBINED WITH CUSTOMERS OF OTHER PRODUCTS SUBJECT OF THE SAME NOTIFICATION): (B)(4). CONSIGNEES RESPONDED TO THE NOTIFICATION: (B)(4). REMAINING 3 CONTACTED VIA MAIL, EMAIL AND TELEPHONE (LAST CONTACT MADE ON 13-JUN-2018).

    Description of Event or Problem · 1

    THE ANTIGEN PROFILE FOR US LICENSED REAGENT RED BLOOD CELLS ALBACYTE® ANTIBODY IDENTIFICATION CELLS 16-CELL (PRODUCT CODE Z473U, LOT NUMBER V194390) SUPPLIED TO CUSTOMERS CONTAINED AN ERROR. DURING IN-HOUSE TESTING OF THE US LICENSED REAGENT RED BLOOD CELL PRODUCTS ALBACYTE® ANTIBODY IDENTIFICATION CELLS 10-CELL NATIVE (PRODUCT CODE Z471U, LOT NUMBER V194387), 10-CELL PAPAIN-TREATED (PRODUCT CODE Z472U, LOT NUMBER V194389), ALBA BIOSCIENCE DISCOVERED AN ERROR IN THE ANTIGEN PROFILES FOR THESE PANELS. CELL # 9 WAS INCORRECTLY REPORTED AS JS(A+) WHILE THE DONOR IS ACTUALLY JS(A-). THE DEVIATION AFFECTS THE PRODUCT/LOT SUBJECT OF THIS REPORT BECAUSE IT SHARES THE SAME DONOR CELL WITH THE ABOVE PRODUCTS. THERE ARE NO ISSUES WITH ANY OTHER ASPECT OF THE PANEL. NO COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD IN RELATION TO THIS INACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044960 ALBACYTE ANTIBODY IDENTIFICATION CELLS 16-CELL REAGENT RED BLOOD CELLS KSZ ALBA BIOSCIENCE LIMITED Z473U V194390 05060242471384

    Patients

    Seq Age Sex Outcome Treatment
    1