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

Catalog Number	0006412
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on (b)(6) 2019 to assess the instrument test well in question, which appeared as visually negative.The camera report was acceptable, and a review of the event log showed no errors during processing.A review of the monolayer check was acceptable.It was noted that the reagent in question was flagged as lower than expected volume for the test in question in the reagent vial, as determined by the pipettor system.The internal immucor number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2019, a customer site reported an unexpectedly negative outcome with anti-d (series 4) monoclonal blend by galileo echo method, when tested on (b)(6) 2019.

• 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: 8484754
• Report Number: 1034569-2019-00073
• Device Sequence Number: 1922347
• Product Code: KSZ
• UDI-Device Identifier: 10888234000556
• UDI-Public: 10888234000556
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

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: No Information
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 0006412
• Device Lot Number: 504815
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR