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	11/15/2018
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 on (b)(4) 2018 to assess the testing instrument in question.The test well images in question were visually negative.Because the product was already expired, the immucor laboratory subsequently performed a dhr review, and determined that the product had met all necessary specifications at the time of the product release.(b)(4).
Event or Problem Description
On (b)(6) 2018, a customer site reported an unexpectedly negative antibody identification when using capture-r ready indicator red cells on a galileo echo instrument, 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: 8135344
• Report Number: 1034569-2018-00272
• Device Sequence Number: 1721571
• Product Code: KSF
• UDI-Device Identifier: 10888234000600
• UDI-Public: 10888234000600
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

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: No Information
• Device Expiration Date: 11/18/2018
• Device Catalogue Number: 0006428
• Device Lot Number: 221196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2018
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR