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 Consequences Or Impact To Patient (2199)
Date of Event	12/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on 20dec2016 to assess the instrument test well image in question, which had visually a slight background of red blood cell adherence.An immucor field service engineer (fse) visited the customer site to assess the testing instrument in question on 21dec2016.The fse adjusted the washer residual volume from 0.86 g to 0.48 g.
Event or Problem Description
On 20dec2016, a customer site reported an unexpected negative antibody screen when using capture-r ready-screen (i and ii) on a galileo neo instrument, when tested on (b)(6) 2016.

• 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: 6239250
• Report Number: 1034569-2017-00020
• Device Sequence Number: 955455
• Product Code: KSZ
• UDI-Device Identifier: 10888234000631
• UDI-Public: 10888234000631
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 102707/0.0
• 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): 01/10/2017

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: 01/31/2017
• Device Catalogue Number: 0006439
• Device Lot Number: X454
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2016
• Initial Report FDA Received Date: 01/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR