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

Catalog Number 0012280

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2016

Event Type  malfunction  

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 Description

On (b)(6) 2016, a customer reported unexpected positive results when using anti-a1 lectin by tube methodology.

• Brand Name: ANTI-A1 LECTIN
• Type of Device: BLOOD GROUPING LECTIN
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• Manufacturer (Section G): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• Manufacturer Contact: howard yorek ; 3130 gateway drive; norcross, GA 30091-5625 ; 7704412051
• MDR Report Key: 6126074
• MDR Text Key: 61096218
• Report Number: 1034569-2016-00312
• Device Sequence Number: 1
• Product Code: KSI
• UDI-Device Identifier: 10888234000952
• UDI-Public: 10888234000952
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK830018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 02/12/2018
• Device Catalogue Number: 0012280
• Device Lot Number: 980012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1