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

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	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2018 immucor technical support used a remote electronic connection method to assess event and the camera report appeared optimal.No blood sample or product was returned to immucor from the customer site for immucor laboratory assessment.On (b)(6) 2018 an immucor field service engineer assessed galileo echo instrument, serial number (b)(4) and as a result adjusted residual volume from 0.12g to 0.09g and recalibrated and refocused the camera; however service ruled out an instrument related problem.Following service a second sample from the same patient reacted as expected using the same instrument and reagent lots.As such, a sample-related problem with the original sample cannot be ruled out as causing the initial reported problem.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 (b)(6) on capture-r ready id lot id360 (expiry july 24, 2018) on echo serial number (b)(4), when tested on (b)(6) 2018.

• Brand Name: CAPTURE-R READY-ID
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 7674562
• Report Number: 1034569-2018-00164
• Device Sequence Number: 1474839
• Product Code: KSZ
• UDI-Device Identifier: 10888234001140
• UDI-Public: 10888234001140
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: 102707/0.0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2018

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: 07/24/2018
• Device Catalogue Number: 0066204
• Device Lot Number: ID360
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR