MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE R READY INDICATOR CELLS; REAGENT RED BLOOD CELLS

Model Number	0006427
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes malfunction events.A review of the events indicated that one (1) patient sample test using capture-r ready indicator cells reagent on an automated blood bank system produced an unexpected negative result for a specific antibody.The result represented a false negative due to prior patient history or, testing completed by other methods that demonstrated the presence of the specific antibody.The malfunction did not show a positive result as expected for the anti-jka antibody on one (1) occasion.Subsequent testing of the reagent retention lot and an antigen validation test of the initial bulk product used for commercial vialing showed acceptable results.Through post event tests and investigations, no specific causes was determined for the malfunction.

• Brand Name: CAPTURE R READY INDICATOR CELLS
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 9650016
• Report Number: 1034569-2020-00014
• Device Sequence Number: 679059
• Product Code: QHT
• UDI-Device Identifier: 10888234000594
• UDI-Public: 10888234000594
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: BK 020053
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0006427
• Device Catalogue Number: 006427
• Device Lot Number: 221404
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1