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	01/19/2018
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 25jan2018, which yielded ntd outcomes, and as a result the customer's issue was not reproduced or confirmed.Immucor performed a dhr review on 30jan2018 which showed that the product met all specifications before being released to market.(b)(4).
Event or Problem Description
On (b)(6) 2018, a european (b)(6) customer site reported an unexpected negative antibody screen when using capture-r ready-screen (pooled cells) with a galileo neo instrument.

• 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: 7271353
• Report Number: 1034569-2018-00044
• Device Sequence Number: 1343223
• 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): 02/14/2018

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: CW336
• 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: 01/19/2018
• Initial Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1