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

Catalog Number	0006440
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The immucor laboratory tested retention product on 24may2017, which performed as expected.The immucor laboratory also tested two (2) returned blood samples ((b)(6)) from the customer site, from the one (1) patient, on 24may2017 with antibody screen on galileo neo, which yielded unexpected negative outcomes, consistent with the customer's observations.
Event or Problem Description
On (b)(6) 2017, a customer site, reported an unexpectedly negative antibody screen when tested on a galileo neo instrument.

• Brand Name: CAPTURE-R READY-SCREEN (I AND II)
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6619772
• Report Number: 1034569-2017-00109
• Device Sequence Number: 10959572
• Product Code: KSZ
• UDI-Device Identifier: 10888234000648
• UDI-Public: 10888234000648
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 102707/0.0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 06/07/2017

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: 07/21/2017
• Device Catalogue Number: 0006440
• Device Lot Number: X468
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR