MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN (3); REAGENT RED BLOOD CELLS

Catalog Number	0066815
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2016, the immucor laboratory received and tested a patient blood sample from the (b)(6) customer site.The immucor laboratory found the antibody screen to be negative with both j076, and j079.J079 was tested on (b)(6) 2016.The immucor laboratory reproduced the customer's issue.The unexpected negative outcomes could be related to being a possible mixture of igm and igg.The immucor laboratory also tested retention product on 18aug2016, which performed as expected.
Event or Problem Description
A complaint was opened on 05sep2016, which indicated that on (b)(6) 2016, a customer site in (b)(6) reported an unexpected negative antibody screen when using capture-r ready-screen (3) on a galileo echo instrument.

• Brand Name: CAPTURE-R READY-SCREEN (3)
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 5980963
• Report Number: 1034569-2016-00252
• Device Sequence Number: 1613275
• Product Code: KSZ
• UDI-Device Identifier: 10888234001478
• UDI-Public: 10888234001478
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: 102707/5045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 09/27/2016

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: 09/20/2016
• Device Catalogue Number: 0066815
• Device Lot Number: J076
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2016
• Initial Report FDA Received Date: 09/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1