MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY INDICATOR RED CELLS; ANTIGLOBULIN COATED RED CELLS

Catalog Number	0006427
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The full number for the product in question is (b)(4) (1/27/2003).Immucor technical support used a remote electronic connection method to assess the instrument test wells in question on (b)(6) 2016, which appeared visually negative.
Event or Problem Description
On (b)(6) 2016, a customer reported an unexpected negative antibody identification when using capture-r ready indicator red cells on a galileo echo instrument.

• Brand Name: CAPTURE-R READY INDICATOR RED CELLS
• Common Device Name: ANTIGLOBULIN COATED RED CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6086806
• Report Number: 1034569-2016-00285
• Device Sequence Number: 838909
• Product Code: KSF
• UDI-Device Identifier: 10888234000594
• UDI-Public: 10888234000594
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BK020053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 11/08/2016

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: Medical Technologist
• Device Expiration Date: 10/27/2016
• Device Catalogue Number: 0006427
• Device Lot Number: 221719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2016
• Initial Report FDA Received Date: 11/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1