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	10/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support advised the customer on (b)(6) 2017 that switching to a new vial of the same lot of reagent resolved the issue.
Event or Problem Description
On (b)(6) 2017, a customer reported some unexpectedly positive results when using anti-k (monoclonal) gamma-clone by galileo echo instrument method.

• 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: 7025795
• Report Number: 1034569-2017-00306
• Device Sequence Number: 156399
• Product Code: KSZ
• UDI-Device Identifier: 10888234001393
• UDI-Public: 10888234001393
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 103497/1014
• 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): 11/13/2017

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: 03/01/2019
• Device Catalogue Number: 0066451
• Device Lot Number: 924610
• 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: 10/19/2017
• Initial Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1