MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-ID EXTEND I; REAGENT RED CELLS

Catalog Number	0006455
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On march 19, 2019 immucor technical support used a remote electronic connection method to review test records on the echo lumena instrument.The camera report was acceptable and review of the event log shows no errors/warnings around date/time of testing.The internal immucor record for this event is mdr (b)(4).
Event or Problem Description
On (b)(6) 2019 a customer reported unexpected negative results using capture-r ready-id extend i on the echo lumena instrument.

• Brand Name: CAPTURE-R READY-ID EXTEND I
• Common Device Name: REAGENT RED CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8523289
• Report Number: 1034569-2019-00075
• Device Sequence Number: 19532699
• Product Code: KSZ
• UDI-Device Identifier: 10888234000679
• UDI-Public: 10888234000679
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: 102707/5030
• 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): 04/17/2019

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: 04/30/2019
• Device Catalogue Number: 0006455
• Device Lot Number: 504815
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 81