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

Catalog Number	0066802
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for capture-r ready-screen 4 lot number k409 was reviewed for e antigen confirmation of cell 2, donor (b)(6), prior to release to market: bulk manufacturing confirmed the presence of the e antigen of cell 2 using red cell bulk material; strength of reactivity was graded 4+; reagent testing lab confirmed the presence of the e antigen of cell 2 during wet plate testing ( strength of reactivity was scored as an 8); quality control confirmed the presence of the e antigen of cell 2 during identity testing using final plate product (strength of reactivity was scored as a 10); all other specifications were deemed acceptable by dhr quality, and product was released.
Event or Problem Description
On (b)(6) 2019 a customer in (b)(6) reported an unexpected negative screen result with capture-r ready-screen 4 run on the european model of the neo iris instrument.

• 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: 8776421
• Report Number: 1034569-2019-00114
• Device Sequence Number: 11397854
• Product Code: KSZ
• UDI-Device Identifier: 10888234001409
• UDI-Public: 10888234001409
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2019

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: No Information
• Device Expiration Date: 06/11/2019
• Device Catalogue Number: 0066802
• Device Lot Number: K409
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR