MAUDE Adverse Event Report: ALBA BIOSCIENCE LIMITED (LTD.) ALBACYTE REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION (16-CELL); KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS

Model Number	Z473U
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An end user reported a dat positive result with cell 15 of albacyte reagent red blood cells for antibody identification (16-cell) product z473u, lot v265925, expiry 04dec23, cell 15 following a confirmed.Off label use of the device.The end user did originally test by the correct method as per ifu and got the expected result.No relevant tests/laboratory data received.

• Brand Name: ALBACYTE REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION (16-CELL)
• Common Device Name: KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS
• Manufacturer (Section D): ALBA BIOSCIENCE LIMITED (LTD.); penicuik EH26 0BF; UK EH26 0BF
• MDR Report Key: 18319074
• Report Number: MW5149182
• Device Sequence Number: 7520439
• Product Code: KSF
• UDI-Device Identifier: 05060242471384
• UDI-Public: 05060242471384
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2023

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: 12/04/2023
• Device Model Number: Z473U
• Device Catalogue Number: Z473U
• Device Lot Number: V265925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown