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	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The immucor laboratory tested retention product on (b)(6) 2017 which performed as expected.The immucor laboratory also tested returned blood sample from the customer site which yielded an unexpected negative outcome, thereby reproducing the customer issue.An immucor field service engineer (fse) previously visited the customer site to assess the testing instrument on (b)(6) 2017.The instrument was only being used for training and validation purposes prior to that date.There was no remote electronic access to the instrument so immucor technical support assessed the testing in question with a faxed report copy.
Event or Problem Description
On (b)(6) 2017, an immucor employee at a (b)(4) customer site reported on behalf of the customer site an unexpected negative antibody validation outcomes when using capture-r ready-screen (3) with a galileo neo instrument, when tested on (b)(6) 2017.

• 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: 7160559
• Report Number: 1034569-2018-00004
• Device Sequence Number: 19298726
• Product Code: KSZ
• UDI-Device Identifier: 10888234001416
• UDI-Public: 10888234001416
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 102707/5045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2018

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: Medical Technologist
• Device Expiration Date: 02/06/2018
• Device Catalogue Number: 0066803
• Device Lot Number: R925
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR