MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-A1 LECTIN; BLOOD GROUPING LECTIN

Catalog Number	0012280
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The use of this product is either by manual test tube or slide method only.The customer site did not return to immucor any remaining customer site lectin product or red blood cell samples under test at the customer site, so the immucor laboratory was unable to investigate the items.Also, because the use of this product is either by manual test tube or slide method only, then immucor technical support could not access any automated test well images using a remote electronic connection method.
Event or Problem Description
On (b)(6) 2016, a customer reported unexpected positive results when using anti-a1 lectin by tube methodology.

• Brand Name: ANTI-A1 LECTIN
• Common Device Name: BLOOD GROUPING LECTIN
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6126074
• Report Number: 1034569-2016-00312
• Device Sequence Number: 13508873
• Product Code: KSI
• UDI-Device Identifier: 10888234000952
• UDI-Public: 10888234000952
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: BK830018
• 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): 11/23/2016

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: 02/12/2018
• Device Catalogue Number: 0012280
• Device Lot Number: 980012
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2016
• Initial Report FDA Received Date: 11/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1