MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-ID EXTEND I; REAGENT RED BLOOD 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	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(4) 2019 immucor technical support used a remote electronic connection method to assess files on echo lumena instrument serial number (b)(4); the camera report was acceptable and the event log indicated no errors at time of testing.On april 16, 2019 an immucor field service technician inspected echo lumena instrument serial number (b)(4) at the customer facility.The technician found the instrument operational and performed a successful unexpected reaction checklist.The immucor internal report record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2019 a customer reported an unexpected negative result with capture-r ready-id extend i on an echo lumena instrument.

• Brand Name: CAPTURE-R READY-ID EXTEND I
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8546161
• Report Number: 1034569-2019-00083
• Device Sequence Number: 1744059
• 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): 04/24/2019

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: DP106
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 96