MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN (3); REAGENT RED BLOOD CELLS

Catalog Number	0066815
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No immucor testing performed because cause determined to be user error covered in labeling.This report submitted in an abundance of caution.Determined to be user error.
Event or Problem Description
On (b)(6) 2016, a customer site in (b)(6) reported an unexpected negative antibody screen when using capture-r ready-screen (3) on a galileo echo instrument.

• Brand Name: CAPTURE-R READY-SCREEN (3)
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6083374
• Report Number: 1034569-2016-00282
• Device Sequence Number: 1514772
• Product Code: KSZ
• UDI-Device Identifier: 10888234001478
• UDI-Public: 10888234001478
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: 102707/5045
• 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): 11/07/2016

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: 11/15/2016
• Device Catalogue Number: 0066815
• Device Lot Number: J079
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2016
• Initial Report FDA Received Date: 11/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1