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	04/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The full number for the product in question is (b)(4) (1/27/2003).Immucor technical support used a remote electronic connection method on 27apr2018 to assess the instrument test well image in question which appeared as visually weak negative, with a halo.The instrument camera setting was optimal and within calibration.The instrument event log showed no error happened during testing.The immucor laboratory was unable to test retention product because the product had already expired.Therefore a dhr review was performed on 03may2018 which showed that the product performed as expected at the time of market release.Complaints of positive reactions being interpreted as negative by the galileo echo camera algorithm are being corrected under design control project 13-005.The immucor technical communication (b)(4) is being used by the lab to visually confirm all negative assay events reported by the echo instrument.The internal immucor tracking number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2018, a customer site reported an unexpectedly negative antibody screen when using capture-r ready indicator red cells by galileo echo method, when tested on (b)(6) 2018.

• 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: 7510968
• Report Number: 1034569-2018-00118
• Device Sequence Number: 275399
• Product Code: KSF
• UDI-Device Identifier: 10888234000600
• UDI-Public: 10888234000600
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/14/2018

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: 04/29/2018
• Device Catalogue Number: 0006428
• Device Lot Number: 221064
• 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: 04/27/2018
• Initial Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1