MAUDE Adverse Event Report: ALBA BIOSCIENCE LIMITED (LTD.) ALBACYTE C3 COATED RED BLOOD CELLS; REAGENT RED BLOOD CELLS

Model Number	Z482U
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports unexpected positive results when using albacyte® c3 coated red blood cells, product z482u, lot v280404, expiry: 24feb2025 to perform quality control of the grifols dat gel card.The customer converted product z482u, lot v280404 from a 2-4% hct to a 0.8% hct concentration to perform quality control with the grifols dat gel card, resulting in a 2+ reaction in the control microtube.The test was repeated with a new vial of z482u, also from lot v280404, using the same lot of grifols dat card and a neutral card.The same results were observed.Customer noted that they previously validated z482u for this purpose and have use it this way for several months.This is the first time experiencing this issue.Us technical advised that z482u is intended for tube technique and requested repeating the test by this method.Customer agreed and reported that negative results were observed when testing z482u with anti-igg in tube.
Additional Manufacturer Narrative
The issue was noted when the product had been converted from a 2-4% red cell suspension to a 0.8% suspension and tested by grifols gel method.Repeat testing by the recommended tube method was satisfactory.Our investigation has consisted of batch manufacturing record review and product review, the outcomes of which are as follows: a bmr review was performed for albacyte® c3 coated red blood cells product z482u lot v280404 which confirmed that all procedures were executed as per standard operating procedure (sop) requirements and results from all in-process and release testing met final product specification limits.No changes were made to the procedures prior to the manufacture and testing of this lot, and no deviations or non-conformances were recorded in the quality management system (qms) that could have impacted product performance.It is important to note that albacyte® c3 coated red blood cells product z482u has been specifically developed and validated for use with tube methods.The red cell concentration, complement coating buffer and preservative formulation are optimised for this application.Alivedx does not have data to support the use of this product when diluted for use in gel systems.The instructions for use (ifu) provided with albacyte® c3 coated red blood cells product z482u clearly state that the recommended techniques are tube techniques only.· tube technique - qc of ahg reagents.· tube technique - use of c3 coated cells as indicator cells for control of ahg testing.Our investigation has determined albacyte® c3 coated red blood cells product z482u lot v280404 met all final product specification requirements when tested by recommended methods and the ifu provided with the product details the recommended tube methods to be used therefore this complaint is deemed unconfirmed.Alba biosicence reference number of this file is (b)(4).

• Brand Name: ALBACYTE C3 COATED RED BLOOD CELLS
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): ALBA BIOSCIENCE LIMITED (LTD.); 5 james hamilton way; milton bridge; penicuik, uk EH26 0BF; UK EH26 0BF
• Manufacturer (Section G): ALBA BIOSCIENCE LIMITED (LTD.); 5 james hamilton way; milton bridge; penicuik, uk EH26 0BF; UK EH26 0BF
• Manufacturer Contact: samuele serfilippi ; 5 james hamilton way; milton bridge; penicuik, uk EH26 -0BF ; UK EH26 0BF
• MDR Report Key: 21342689
• Report Number: 3011683976-2025-00001
• Device Sequence Number: 9003351
• Product Code: QHT
• UDI-Device Identifier: 05060242471612
• UDI-Public: 05060242471612
• 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: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: 02/24/2025
• Device Model Number: Z482U
• Device Lot Number: V280404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown