MAUDE Adverse Event Report: ALBA BIOSCIENCE LIMITED ALBACYTE EXPANDED RH NEGATIVE ANTIBODY SCREEN; REAGENT RED BLOOD CELLS

Model Number	Z464U
Medical Device Problem Codes	Inadequate Instructions for Healthcare Professional (1319); Inaccurate Information (4051)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: ALBACYTE EXPANDED RH NEGATIVE ANTIBODY SCREEN
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): ALBA BIOSCIENCE LIMITED; 21 ellen's glen road; edinburgh, EH17 7QT; UK EH17 7QT
• MDR Report Key: 8206178
• Report Number: 3003580203-2018-00007
• Device Sequence Number: 2792243
• Product Code: KSZ
• UDI-Device Identifier: 05060242471377
• UDI-Public: 05060242471377
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BL125337/25
• 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: No Information
• Device Expiration Date: 09/17/2018
• Device Model Number: Z464U
• Device Catalogue Number: Z464U
• Device Lot Number: V198377
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2018
• 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