MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY INDICATOR RED CELLS; ANTIGLOBULIN COATED RED CELLS

Catalog Number	0006428
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The full number for the product in question is bk020053 (1/27/03).Immucor technical support used a remote electronic connection method to assess the instrument test well images in question on 01may2018, which visually appeared positive.A review of the check image well showed a bubble in the 3rd screening well, and the event log showed that there was a warning for the reagent in question of a remaining liquid volume lower than expected.The immucor laboratory tested retention product on 17may2018 and 21may2018 against antibody screen strip r969, which performed as expected.Complaints of positive reactions being interpreted as negative by the galileo echo camera algorithm are being corrected under design control project (b)(4).The echo instrument is performing as expected with the exception of the camera module ability to appropriately identify some true positive results.The immucor technical communication (b)(4) is being used by the lab to visually confirm all negative assay events reported by the echo instrument.(b)(4).
Event or Problem Description
On (b)(6) 2018, a customer site reported an unexpected negative antibody screen when using capture-r ready indicator red cells by galileo echo.

• Brand Name: CAPTURE-R READY INDICATOR RED CELLS
• Common Device Name: ANTIGLOBULIN COATED RED CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 7545105
• Report Number: 1034569-2018-00127
• Device Sequence Number: 1318135
• Product Code: KSF
• UDI-Device Identifier: 10888234000600
• UDI-Public: 10888234000600
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: BK020053
• 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): 05/25/2018

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: 05/20/2018
• Device Catalogue Number: 0006428
• Device Lot Number: 221081
• 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: 05/01/2018
• Initial Report FDA Received Date: 05/25/2018
• 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