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

Catalog Number	0006440
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method to assess the testing instrument in question on (b)(6) 2018 and determined that the event log showed no errors during testing and that the rois were centered, and that there were no issues during strip read, strip exit, and of reagent addition.The instrument test wells in question were also visually weakly positive.The immucor laboratory tested retention product on (b)(6) 2018 which performed as expected.The immucor laboratory also tested a returned blood sample ((b)(4)) on (b)(6) 2018 which yielded an equivocal outcome with retention product.The internal immucor tracking number for this record is (b)(4).
Event or Problem Description
On (b)(6) 2018, an immucor employee reported on behalf of a customer site, an unexpectedly negative antibody screen when using capture-r ready-screen (i and ii) with a galileo neo instrument, when tested on (b)(6) 2018.

• 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: 7448368
• Report Number: 1034569-2018-00104
• Device Sequence Number: 1124561
• Product Code: KSZ
• UDI-Device Identifier: 10888234000648
• UDI-Public: 10888234000648
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2018

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: 04/18/2018
• Device Catalogue Number: 0006440
• Device Lot Number: X480
• 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: 04/03/2018
• Initial Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1