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	12/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2018 immucor technical support used a remote electronic connection method to review results for the issue described.The camera report appeared acceptable and no instrument problem was identified.On (b)(6) 2018, immucor tested selected cells from retention capture-r ready-id lot id369 in manual capture with anti-k lot k012512f.Controls performed as expected and cells 6 and 8 (k positive) resulted positive as expected.Retention product performed as expected.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) 2018 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: 8253557
• Report Number: 1034569-2019-00023
• Device Sequence Number: 11164627
• Product Code: KSZ
• UDI-Device Identifier: 10888234001140
• UDI-Public: 10888234001140
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: 0066204
• Device Lot Number: ID369
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2018
• Initial Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR