MAUDE Adverse Event Report: ALBA BIOSCIENCE LIMITED ALBACLONE ANTI-N; BLOOD GROUPING REAGENT

Model Number	Z176U
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: ALBACLONE ANTI-N
• Common Device Name: BLOOD GROUPING REAGENT
• Manufacturer (Section D): ALBA BIOSCIENCE LIMITED; 21 ellen's glen road; edinburgh, EH17 7QT; UK EH17 7QT
• MDR Report Key: 8206172
• Report Number: 3003580203-2018-00006
• Device Sequence Number: 16842149
• Product Code: KSZ
• UDI-Device Identifier: 05060242471001
• UDI-Public: 05060242471001
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: BL125309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2019
• Device Model Number: Z176U
• Device Catalogue Number: Z176U
• Device Lot Number: V185490
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 12/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1