MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE R SELECT; REAGENT RED BLOOD CELLS

Model Number	0006446
Medical Device Problem Codes	False Negative Result (1225); False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 1 malfunction events.A review of the events indicated that two (2) patient sample tests using the capture-r select reagent on automated blood bank systems produced an unexpected false negative result with a dat assay and an unexpected compatible crossmatch result.Through post event tests and investigations, no specific causes were determined for the malfunctions.

• Brand Name: CAPTURE R SELECT
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross, ga
• MDR Report Key: 10347309
• Report Number: 1034569-2020-00054
• Device Sequence Number: 16690779
• Product Code: QHT
• UDI-Device Identifier: 10888234000655
• UDI-Public: 10888234000655
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: BK040024
• 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): 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0006446
• Device Catalogue Number: 0006446
• Device Lot Number: SC656,SC671
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1