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

Catalog Number	0006428
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2017
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 reviewed faxed copies of instrument reports on 09jan2018, and also used a remote elctronic connection method on 09jan2018 to assess the instrument test well image in question, and determined that the instrument test well images in question were visually negative.The product had already expired, so the immucor laboratory was able to review previous testing of retention product from 05dec2017, which performed as expected at that time.
Event or Problem Description
On (b)(6) 2017, a customer site reported an unexpected negative antibody screen when using capture-r ready indicator red cells on a galileo neo instrument, when tested on (b)(6) 2017.

• 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: 7192047
• Report Number: 1034569-2018-00012
• Device Sequence Number: 112028
• Product Code: KSF
• UDI-Device Identifier: 10888234000600
• UDI-Public: 10888234000600
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: BK020053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 01/15/2018

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: Medical Technologist
• Device Expiration Date: 12/21/2017
• Device Catalogue Number: 0006428
• Device Lot Number: 221979
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 01/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 57