MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-D SERIES 4 (MONOCLONAL BLEND); BLOOD GROUPING REAGENT

Catalog Number	0006412
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer site declined immucor access to testing instrument.Site declined access to instrument.
Event or Problem Description
On 0(b)(6) 2016, a customer reported an unexpected positive result when using anti-d (monoclonal blend) series 4 on a galileo neo instrument.

• Brand Name: ANTI-D SERIES 4 (MONOCLONAL BLEND)
• Common Device Name: BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 5772204
• Report Number: 1034569-2016-00153
• Device Sequence Number: 10768729
• Product Code: KSZ
• UDI-Device Identifier: 10888234000556
• UDI-Public: 10888234000556
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: 103523/0.0
• 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): 07/06/2016

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: 06/24/2017
• Device Catalogue Number: 0006412
• Device Lot Number: 504981
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2016
• Initial Report FDA Received Date: 07/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1