MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-C SERIES 1 (MONOCLONAL REAGENT); BLOOD GROUPING REAGENT

Catalog Number	0066425
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Advised customer review of the maintenance shows all maintenance up to date the day of testing, the camera appeared to be operating as expected.The event log shows no errors during testing.Qc and all other samples run the same day and around the same time as the sample in question reacted as expected.The sample was retested and this time resulted negative as expected on the neo.This suggests the instrument and reagents are performing as expected.Advised customer that the sample cannot be ruled out as the cause of this unexpected positive reaction.
Event or Problem Description
On (b)(6) 2016, a customer reported an unexpected reaction on the galileo neo instrument when testing a donor sample.They received a 2+ reaction on the neo with anti-c.Historically the donor is anti-c negative.

• Brand Name: ANTI-C SERIES 1 (MONOCLONAL REAGENT)
• Common Device Name: BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 5689492
• Report Number: 1034569-2016-00115
• Device Sequence Number: 13460064
• Product Code: KSZ
• UDI-Device Identifier: 10888234001386
• UDI-Public: 10888234001386
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 103480/0.0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 05/31/2016

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: 08/26/2017
• Device Catalogue Number: 0066425
• Device Lot Number: 945111
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2016
• Initial Report FDA Received Date: 05/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1