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

Catalog Number	0066213
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The immucor laboratory tested retention product on 01feb2018, which performed as expected.The immucor laboratory also tested a returned blood sample from the customer site with retention product on 01feb2018, which yielded the expected positive outcomes, and as a result the customer's issue was not reproduced or confirmed.Immucor technical support used a remote electronic connection method on (b)(6) 2018 to assess the test wells in question on the testing instrument, which visually appeared as negative, consistent with the instrument unexpected negative outcome.(b)(4).
Event or Problem Description
On 23feb2018, it was determined that a european (b)(6) customer site communication from (b)(6) 2018 was reportable as an unexpected negative antibody screen when using capture-r ready-screen (pooled cells) with a galileo instrument, when tested on (b)(6) 2018.

• Brand Name: CAPTURE-R READY-SCREEN (POOLED CELLS)
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 7346091
• Report Number: 1034569-2018-00070
• Device Sequence Number: 39380
• Product Code: KSZ
• UDI-Device Identifier: 10888234001171
• UDI-Public: 10888234001171
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: 102707 / 0.0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 03/16/2018

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: 03/06/2018
• Device Catalogue Number: 0066213
• Device Lot Number: CW337
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1