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

Catalog Number	0066803
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The same patient sample ((b)(6)) resulted in an unexpected negative screen on (b)(6) 2018 using capture-r ready screen 3 lot number r990 (expiry september 18, 2018) with capture-r ready indicator cell lot 221161 on the echo lumena instrument serial number (b)(4); that event was reported previously under mfg report # 1034569-2018-00232 on october 25, 2018.On october 25, 2018 immucor confirmed presence of the c antigen on cell 1 of retention capture-r ready screen 3 lot number r001 in manual capture with retention anti-c lot number dl17022c.Controls performed as expected and cell 1 resulted 3+ positive.Retention product performed as expected.The immucor internal record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2018 a customer reported unexpected negative reactivity with capture-r ready-screen 3 on the echo lumena 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: 8054914
• Report Number: 1034569-2018-00255
• Device Sequence Number: 1914822
• Product Code: KSZ
• UDI-Device Identifier: 10888234001416
• UDI-Public: 10888234001416
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: 102707/5045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2018

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: 11/13/2018
• Device Catalogue Number: 0066803
• Device Lot Number: R001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR