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	05/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The full number for the product in question is (b)(4).Immucor technical support used a remote electronic connection method to assess the instrument test well images in question which visually appeared as tight buttons, with the button intact.The immucor laboratory tested retention product on (b)(6) 2018 which performed as expected.The immucor laboratory also tested a returned blood sample by various methods.This returned blood sample ((b)(4)) was a thawed previously-frozen plasma sample which was drawn 11/10.This sample was tested against retention product on (b)(6) 2018, which yielded unexpected negative outcomes, consistent with the customer's findings.The customer issue was reproduced with the returned sample.The returned blood sample was also tested by manual test tube method on (b)(6) 2018, using panocreen lot number 16248, combined with both immuadd (lot number 357018-1) and also gamma peg (lot number 336032) as enhancement, and both sets of manual tests yielded expected positive outcomes, consistent with what the customer reported.The internal immucor record number for this report is (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, 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: 7550727
• Report Number: 1034569-2018-00130
• Device Sequence Number: 1775127
• Product Code: KSF
• UDI-Device Identifier: 10888234000600
• UDI-Public: 10888234000600
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/29/2018

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: 05/10/2018
• Initial Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR