MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-B (MURINE MONOCLONAL) SERIES 3; BLOOD GROUPING REAGENT

Catalog Number	0006406
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support assessed the instrument test well images in question on (b)(6) 2017 from reports that had been supplied from the customer site via email, and determined that they appeared consistent with the instrument result outputs.An immucor field service engineer (fse) visited the customer site on (b)(4) 2017 to assess the testing instrument, and the fse determined that the instrument was operating as expected.
Event or Problem Description
On (b)(6) 2017, a customer reported an unexpected positive result when using anti-b (murine monoclonal) series 3 on a galileo instrument, when tested on (b)(6) 2017.

• Brand Name: ANTI-B (MURINE MONOCLONAL) SERIES 3
• Common Device Name: BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6673651
• Report Number: 1034569-2017-00121
• Device Sequence Number: 1883005
• Product Code: KSZ
• UDI-Device Identifier: 10888234000532
• UDI-Public: 10888234000532
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: 102692/1009
• 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): 06/28/2017

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: 12/07/2018
• Device Catalogue Number: 0006406
• Device Lot Number: 203681
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR