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	01/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The full number for the product in question is bk020053 ((b)(6) 2003).Immucor technical support used a remote electronic connection method on (b)(6) 2018 to assess the instrument test well image in question.Immucor did a dhr review on 26jan2018, after the product had already expired, which showed that all specifications had been met before the product was released to market.(b)(4).This report is a correction report for (b)(4) because the original record had a set of erroneous hospital demographic information for the hospital.The erroneous information in the original (b)(4) was from a hospital in (b)(6).The corrected and accurate demographic information in this (b)(4) report is for the hospital in flushing ny.
Event or Problem Description
On 19jan "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) 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: 7270265
• Report Number: 1034569-2018-00043
• Device Sequence Number: 1367933
• Product Code: KSF
• UDI-Device Identifier: 10888234000600
• UDI-Public: 10888234000600
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/14/2018

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: 01/18/2018
• Device Catalogue Number: 0006428
• Device Lot Number: 221996
• 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: 01/19/2018
• Initial Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR