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	04/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic access method on (b)(6) 2017 to assess the instrument test well image in question.The electronic file containing the result had already been archived, so the assessment could only be done when the archived disc was made available for viewing.It was determined that the instrument test well in question was visually positive, consistent with the unexpected instrument output.An immucor field service engineer (fse) visited the customer site on (b)(6) 2017 to assess the testing instrument and found that the probe was damaged.The fse subsequently replaced that probe.
Event or Problem Description
On (b)(6) 2017, a customer reported an unexpected positive result when using anti-d (monoclonal blend) series 4 on a galileo echo instrument, when tested on (b)(6) 2017 with the weak d assay.

• 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: 6549256
• Report Number: 1034569-2017-00089
• Device Sequence Number: 19077202
• Product Code: KSZ
• UDI-Device Identifier: 10888234000556
• UDI-Public: 10888234000556
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/05/2017

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: 11/28/2018
• Device Catalogue Number: 0006412
• Device Lot Number: 504745L
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2017
• Initial Report FDA Received Date: 05/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR