MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-ID; AUTOMATED BLOOD BANK SYSTEM

Catalog Number	0066204
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2018 an immucor technical support used a remote electronic connection method to transfer camera images, event logs and result batches for the issue described.Based on the reactivity pattern, the characteristic of this anti-k is showing dosage where heterozygous k+ cells may or may not all react.The donor cell that is reacting negative has been dna typed and confirmed to be k+.This is a sample related issue.The immucor internal record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2018 a customer reported that they received unexpected negative reactions with capture-r ready-id on an echo instrument.

• Brand Name: CAPTURE-R READY-ID
• Common Device Name: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8257234
• Report Number: 1034569-2019-00027
• Device Sequence Number: 2106087
• Product Code: KSZ
• UDI-Device Identifier: 10888234001140
• UDI-Public: 10888234001140
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: BL102707/0.0
• 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): 01/17/2019

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: 02/19/2019
• Device Catalogue Number: 0066204
• Device Lot Number: ID372
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR