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

Catalog Number	0066214
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(4) 2019 immucor technical support used a remote electronic connection method to review results for the issue described.The errors were noted and no instrument problem was identified.On january 3, 2019 immucor performed retention testing with capture-r ready-id lot id369 and retention vial of capture-r indicator cell lot 221230 with one anti e-positive and one anti e-negative in-house sample.Both samples reacted as expected.Anti e-positive sample reacted positive with cells 1, 3, 6 and 14 as expected.Anti e-negative sample reacted negative with all cells.On january 3, 2019 an immucor service technician examined the echo v2.0 instrument serial number (b)(4) at the customer site.The technician performed unexpected reaction checklist and cleaned probe rinse station proactively; instrument was found to be in specs for all modules and released to customer for use.No sample or product was returned to immucor for evaluation.The immucor internal report record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2019 a customer reported that they received unexpected negative reactions with capture-r ready-id on an echo v2.0 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: 8268760
• Report Number: 1034569-2019-00033
• Device Sequence Number: 19341750
• Product Code: KSZ
• UDI-Device Identifier: 10888234001188
• UDI-Public: 10888234001188
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 01/16/2019

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: 01/08/2019
• Device Catalogue Number: 0066214
• Device Lot Number: ID369
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/01/2019
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR