MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY INDICATOR RED CELLS; KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS

Catalog Number	0006428
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2019 immucor technical support used a remote electronic connection method to assess files on echo lumena instrument serial number (b)(4); the camera report and the event log were both acceptable.On (b)(6) 2019 an immucor technical services explained to the customer that the patient sample cannot be ruled out as the cause due to fact that the xm was compatible on both echos, and with the gel and tube methods.The immucor internal report record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2019 a customer reported unexpected negative results for a crossmatch on the echo lumena instrument.

• Brand Name: CAPTURE-R READY INDICATOR RED CELLS
• Common Device Name: KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8540049
• Report Number: 1034569-2019-00080
• Device Sequence Number: 1744511
• Product Code: KSF
• UDI-Device Identifier: 10888234000600
• UDI-Public: 10888234000600
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: BK020053
• 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): 04/23/2019

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: 03/31/2019
• Device Catalogue Number: 0006428
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR