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

Catalog Number	0006412
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on 31may2018 to assess the instrument test well images in question, which appeared as visually positive.There were no errors during processing, and the camera files were acceptable.The immucor technical communication (b)(4) is being used by the lab to visually confirm all negative assay events reported by the echo instrument.Complaints of positive reactions being interpreted as negative by the galileo echo camera algorithm are being corrected under design control project 13-005.(b)(4).
Event or Problem Description
On (b)(6) 2018, a customer site reported an unexpectedly positive outcome with anti-d (series 4) monoclonal blend on a galileo echo 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: 7635210
• Report Number: 1034569-2018-00150
• Device Sequence Number: 2143643
• Product Code: KSZ
• UDI-Device Identifier: 10888234000556
• UDI-Public: 10888234000556
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/25/2018

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: 12/31/2019
• Device Catalogue Number: 0006412
• Device Lot Number: 504796
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR