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

Catalog Number	0006427
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2017
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 on (b)(4) 2017 to assess the instrument test well images in question, and determined that the instrument test well images in question were visually negative.The immucor laboratory had previously tested retention product on (b)(4) 2017 which had performed as expected.At the time of the customer complaint, the product was already expired.
Event or Problem Description
On (b)(6) 2017, a customer site reported an unexpected negative antibody screen when using capture-r ready indicator red cells on a galileo echo instrument, when tested on (b)(6) 2017.A subsequent blood sample ((b)(6)) for the same patient also yielded an unexpected negative screen outcome when tested on (b)(6) 2017.

• 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: 7054455
• Report Number: 1034569-2017-00321
• Device Sequence Number: 16680343
• Product Code: KSF
• UDI-Device Identifier: 10888234000594
• UDI-Public: 10888234000594
• 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): 11/22/2017

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: 10/27/2017
• Device Catalogue Number: 0006427
• Device Lot Number: 221947
• 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: 10/30/2017
• Initial Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR