MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY INDICATOR RED CELLS; ANTIGLOBULIN COATED RED CELLS

Catalog Number 0006428

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

The full number for the product in question is bk020053 (1/27/03).Immucor technical support used a remote electronic connection method to assess test wells on the testing instrument on (b)(6) 2016.The test well image in question was visually (b)(6).

Event Description

On (b)(6) 2016, a customer reported an unexpected (b)(6) antibody screen when using capture-r ready indicator red cells on a galileo echo instrument.

• Brand Name: CAPTURE-R READY INDICATOR RED CELLS
• Type of Device: ANTIGLOBULIN COATED RED CELLS
• 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: 5967195
• MDR Text Key: 55317583
• Report Number: 1034569-2016-00245
• Device Sequence Number: 1
• Product Code: KSF
• UDI-Device Identifier: 10888234000600
• UDI-Public: 10888234000600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK020053
• 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: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 09/23/2016
• Device Catalogue Number: 0006428
• Device Lot Number: 221701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 47 YR