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

Catalog Number	0066814
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On april 30, 2019 immucor tested sample id (b)(4) using retention capture-r ready-screen 3 lot number e331 (expiry april 30, 2019) using capture-r ready indicator red cells lot number 221302 on the galileo neo instrument serial number (b)(4); sample reacted equivocal with cell 1 (24,9) and 3 (25,1).Known in-house samples were run with the customer sample; the 2 known negative in-house donor samples reacted negative as expected and the 2 known anti-e positive in-house sample reacted positive as expected.Retention product performed as expected with all in-house samples.Customer issue was determined to be sample-related (antibodies present in concentrations too low to be detected by the test methods employed).The immucor internal report record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2019 a customer in (b)(6) reported unexpected negative antibody screen results with capture-r ready-screen 3.

• 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: 8640102
• Report Number: 1034569-2019-00102
• Device Sequence Number: 2299432
• Product Code: KSZ
• UDI-Device Identifier: 10888234001461
• UDI-Public: 10888234001461
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/24/2019

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: 04/30/2019
• Device Catalogue Number: 0066814
• Device Lot Number: E331
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1