BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBACLONE ANTI-N

    MDR report key: 8206172 · Received December 31, 2018

    Report

    Report Number
    3003580203-2018-00006
    Event Type
    Malfunction
    Date Received
    December 31, 2018
    Date of Event
    March 26, 2018
    Report Date
    December 31, 2018
    Manufacturer
    ALBA BIOSCIENCE LIMITED
    Product Code
    KSZ
    UDI-DI
    05060242471001
    PMA / PMN Number
    BL125309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS ORIGINALLY REPORTED TO FDA ON 14-MAY-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 ESTABLISHMENT INSPECTION 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. A FALSE POSITIVE N ANTIGEN IN A DONOR UNIT WOULD NOT CAUSE HARM TO A PATIENT. HOWEVER THE MALFUNCTION 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 WAS SENT TO THE AFFECTED END USERS SUPPLIED WITH LOT V185490 WAS INITIATED ON 14-MAY-2018 REQUESTING THEM TO DISCARD ANY STOCK OF AFFECTED PRODUCT AND REVIEW RESULTS PREVIOUSLY OBTAINED WITH IT. STOCK OF LOT V185490 WHICH HAS NOT BEEN DISTRIBUTED HAS BEEN QUARANTINED AND DESTROYED. THE ASSIGNED FDA RECALL COORDINATOR ((B)(6)) WAS INFORMED OF THE RECALL ACTIVITY ON 14-MAY-2018. THE RECALL RECONCILIATION WAS COMPLETED ON 13-JUN-2018 WHEN A RESPONSE HAS BEEN RECEIVED FROM ALL THE AFFECTED END USERS.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED ON (B)(6) 2018 REGARDING FALSE POSITIVE REACTIVITY FOR ALBACLONE® ANTI-N (PRODUCT CODE Z176U), LOT V185490 WHEN TESTING A SAMPLE FROM A DONOR WHO HAD PREVIOUSLY BEEN MOLECULARLY TYPED AS NEGATIVE FOR THE N ANTIGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044961 ALBACLONE ANTI-N BLOOD GROUPING REAGENT KSZ ALBA BIOSCIENCE LIMITED Z176U V185490 05060242471001

    Patients

    Seq Age Sex Outcome Treatment
    1