BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBACYTE ANTIBODY IDENTIFICATION CELLS 10-CELL PAPAINISED

    MDR report key: 8206170 · Received December 31, 2018

    Report

    Report Number
    3003580203-2018-00002
    Event Type
    Malfunction
    Date Received
    December 31, 2018
    Date of Event
    October 2, 2017
    Report Date
    December 31, 2018
    Manufacturer
    ALBA BIOSCIENCE LIMITED
    Product Code
    KSZ
    UDI-DI
    05060242471193
    PMA / PMN Number
    BL125337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    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 CORRECTION AT THE TIME OF DISTRIBUTION TO END USERS AND THEREFORE MEETS THE REPORTING CRITERIA DESCRIBED IN THE FDA GUIDANCE ON MDR FOR MANUFACTURERS. A NOTIFICATION ACCOMPANIED ANY PRODUCTS FROM LOT V187500 SUBSEQUENTLY SHIPPED TO END USERS, REQUESTING THEM TO DISCARD THE ORIGINAL (I.E. INCORRECT) ANTIGEN PROFILE CONTAINED WITHIN THE SECONDARY PACKAGING OF LOT V187500 AND REPLACE IT WITH A CORRECTED VERSION PROVIDED WITH THE NOTIFICATION. THE ASSIGNED FDA RECALL COORDINATOR ((B)(6)) WAS INFORMED OF THE CORRECTION ON 03-OCT-2017. BPD ADDITIONAL INFORMATION WAS NOT REQUESTED; HOWEVER, ON 20-NOV-2017 ALBA BIOSCIENCE RECEIVED A LETTER FROM FDA ((B)(6)) STATING THAT THE ACTIONS TAKEN BY ALBA BIOSCIENCE HAVE BEEN APPROPRIATE AND THAT THERE HAS BEEN PROPER DISPOSITION OF THE PRODUCT AND THAT FDA CONSIDERED THE MARKET WITHDRAWAL COMPLETED.

    Description of Event or Problem · 1

    THE ANTIGEN PROFILE FOR US LICENSED REAGENT RED BLOOD CELLS ALBACYTE® ANTIBODY IDENTIFICATION CELLS 10-CELL PAPAIN-TREATED (PRODUCT CODE Z472U, LOT NUMBER V187500) SUPPLIED TO CUSTOMERS CONTAINED AN ERROR. THIS WAS NOTED THROUGH A COMPLAINT RECEIVED FOR CE MARKED PRODUCT ALBACYTE REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION (PRODUCT CODE "Z472"), LOT NO. V187499) WHICH IS MANUFACTURED FROM THE SAME STARTING MATERIALS AND USING THE SAME MANUFACTURING PROCESS AS THE PRODUCT SUBJECT OF THIS REPORT. THE INVESTIGATION INDICATES THAT THE UNEXPECTED REACTIONS WITH ANTI-C ARE DUE TO CELL 2 AND CELL 3 OF THE PANEL BEING SWAPPED AT THE TIME OF LABELING OF THE PRIMARY CONTAINERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044829 ALBACYTE ANTIBODY IDENTIFICATION CELLS 10-CELL PAPAINISED REAGENT RED BLOOD CELLS KSZ ALBA BIOSCIENCE LIMITED Z472U V187500 05060242471193

    Patients

    Seq Age Sex Outcome Treatment
    1