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	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The error within the antigen profile is not considered critical to the performance of the product as the other two cells present within the lot are p1 positive and are stated as such.The relevant regulatory guidelines do not state a requirement for the presence of a negative p1 cell therefore compliance of this lot to cfr.660.33 has not been compromised.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.The impacted lot expired on october 15, 2018.A notification was sent to the affected end users on october 18, 2018 requesting them to review all test results generated using the impacted lot.A corrected antigen profile was also provided.A bpdr was submitted on october 18, 2018 and the assigned fda recall coordinator (laura hyeronimus) was informed on the same day.The delay in the submission of this mdr is due to issues encountered during the set up of the electronic submission.
Event or Problem Description
The antigen profile for us licensed reagent red blood cells, expanded rh negative antibody screen (product code z464u, lot number v199492) supplied to customers contained an error.During in-house testing of the us licensed reagent red blood cell products expanded rh negative antibody screen (product code z464u, lot number v199492), alba bioscience discovered an error in the antigen profiles for the panel.Cell 2 is stated as p1 negative where the cell has been tested and shown to be p1 positive.

• 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: 8159675
• Report Number: 3003580203-2018-00001
• Device Sequence Number: 13814727
• Product Code: KSZ
• UDI-Device Identifier: 05060242471377
• UDI-Public: 05060242471377
• Combination Product (Y/N): N
• PMA/510(K) Number: BL125337/25
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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: 10/15/2018
• Device Model Number: Z464U
• Device Catalogue Number: Z464U
• Device Lot Number: V199492
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1