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

Catalog Number	0006412
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support assessed the test well images on the testing instrument using a remote electronic connection method on (b)(6) 2016.The images of the instrument test wells were visually consistent with the negative instrument test result outputs.The immucor laboratory tested retention product on (b)(6) 2016 which performed as expected.The immucor laboratory also tested a blood sample on (b)(6) 2016, which had been submitted from the customer site, and this testing was not able to duplicate the customer's findings.
Event or Problem Description
On (b)(6) 2016, a customer reported an unexpected negative result when using anti-d (monoclonal blend) series 4 on a galileo neo instrument, when tested on (b)(6) 2016.

• 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: 5548233
• Report Number: 1034569-2016-00067
• Device Sequence Number: 517142
• Product Code: KSZ
• UDI-Device Identifier: 10888234000556
• UDI-Public: 10888234000556
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/05/2016

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: 09/22/2017
• Device Catalogue Number: 0006412
• Device Lot Number: 504990
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2016
• Initial Report FDA Received Date: 04/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR