MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY INDICATOR RED CELLS; QUALITY CONTROL KITS FOR BLOOD BANKING REAGENTS

Catalog Number	0006428
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 april 15, 2019 immucor technical support used a remote electronic connection method to assess files on galileo echo v2 instrument serial number (b)(4); the camera report was acceptable and the event log indicated no errors at time of testing.Unable to rule out capture-r ready indicator red cells lot number 221291 as testing done april 15, 2019 used a different lot cric than the testing done april 3, 2019; however, the anti-e is showing dosage as heterozygous e cells are not reacting.On april 16, 2019 an immucor field service technician inspected galileo echo v2 instrument serial number (b)(4) at the customer facility.The technician found the instrument operational and performed a successful unexpected reaction checklist.Found instrument to be fully operational and to be operating in specification.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 for a screen assay on a galileo echo v2 instrument.

• Brand Name: CAPTURE-R READY INDICATOR RED CELLS
• Common Device Name: QUALITY CONTROL KITS FOR BLOOD BANKING REAGENTS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8558105
• Report Number: 1034569-2019-00088
• Device Sequence Number: 14030563
• Product Code: KSF
• UDI-Device Identifier: 10888234000600
• UDI-Public: 10888234000600
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: BK020053
• 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): 04/26/2019

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: 04/14/2019
• Device Catalogue Number: 0006428
• Device Lot Number: 221291
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR