MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-ID EXTEND I; REAGENT RED BLOOD CELLS

Catalog Number	0006455
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support performed a dhr review for jka antigen status on 10jan2017 and 13jan2017 because the product had already expired.This dhr review showed that all specifications had been met for the product to be relased to market on 31aug2016.
Event or Problem Description
On (b)(6) 2017, it was determined that a customer site had an unexpected negative antibody identification when using capture-r ready-id extend i when used on a galileo echo instrument, serial number (b)(4).

• Brand Name: CAPTURE-R READY-ID EXTEND I
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6290544
• Report Number: 1034569-2017-00027
• Device Sequence Number: 19054035
• Product Code: KSZ
• UDI-Device Identifier: 10888234000679
• UDI-Public: 10888234000679
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: 102707/5030
• 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): 01/31/2017

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: 11/29/2016
• Device Catalogue Number: 0006455
• Device Lot Number: DP090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2017
• Initial Report FDA Received Date: 01/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR