MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN (I AND II); REAGENT RED BLOOD CELLS

Catalog Number	0006439
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support received the instrument test well image files in question, from the archived records, by email method on 07apr2017, and determined that the instrument test well image in question visually had a slight red blood cell adherence.The immucor employee present at the customer site stated that the issue was resolved by a camera replacement done on (b)(6) 2017.
Event or Problem Description
On (b)(6) 2017, an immucor employee, while visiting a customer site, reported an unexpectedly negative antibody screen when tested on a galileo neo instrument, when tested on (b)(6) 2017.

• Brand Name: CAPTURE-R READY-SCREEN (I AND II)
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6512687
• Report Number: 1034569-2017-00081
• Device Sequence Number: 13576917
• Product Code: KSZ
• UDI-Device Identifier: 10888234000631
• UDI-Public: 10888234000631
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 102707/0.0
• 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): 04/21/2017

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: 05/16/2017
• Device Catalogue Number: 0006439
• Device Lot Number: X463
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2017
• Initial Report FDA Received Date: 04/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR