MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN (4); REAGENT RED BLOOD CELLS

Catalog Number	0066812
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product expired before an investigation could be initiated.However, a documented dhr review had previously been performed which did not yield any anomalies.Product expired before investigation.
Event or Problem Description
On (b)(6) 2016, a (b)(6) customer site originally reported an unexpected negative antibody screen when using capture-r ready-screen (4), but with inadequate information.

• Brand Name: CAPTURE-R READY-SCREEN (4)
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 5939396
• Report Number: 1034569-2016-00234
• Device Sequence Number: 11069415
• Product Code: KSZ
• UDI-Device Identifier: 10888234001447
• UDI-Public: 10888234001447
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: 102707/0.0
• 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): 09/09/2016

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: 05/17/2016
• Device Catalogue Number: 0066812
• Device Lot Number: K372
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2016
• Initial Report FDA Received Date: 09/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1