MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-K (MONOCLONAL) GAMMA-CLONE; BLOOD GROUPING REAGENT

Catalog Number	0066451
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support use a remote electronic connection method to access and assess the test wells on (b)(6) 2016.The test well in question visually appeared negative, which was consistent with the instrument output.The immucor laboratory tested retention product on (b)(6) 2016, which performed as expected.An immucor field service engineer (fse) visited the customer site on (b)(6) 2016 to assess the testing instrument and found that the instrument was operating as expected.
Event or Problem Description
On (b)(6) 2016, a customer reported an unexpected negative result when using gamma-clone anti-k (monoclonal) with galileo neo testing methodology, when tested on (b)(6) 2016.

• Brand Name: ANTI-K (MONOCLONAL) GAMMA-CLONE
• Common Device Name: BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 5545849
• Report Number: 1034569-2016-00066
• Device Sequence Number: 601413
• Product Code: KSZ
• UDI-Device Identifier: 10888234001393
• UDI-Public: 10888234001393
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 103497/1014
• 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): 04/04/2016

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: 05/15/2017
• Device Catalogue Number: 0066451
• Device Lot Number: 924570
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2016
• Initial Report FDA Received Date: 04/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1