MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-E (MONOCLONAL) GAMMA-CLONE; BLOOD GROUPING REAGENT

Catalog Number	0066422
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on 24aug2017 to assess the instrument test well image in question, which appeared as visually negative.
Event or Problem Description
On (b)(6) 2017, a customer reported an unexpected negative result when using anti-e (monoclonal) gamma-clone by galileo echo instrument method, when tested on (b)(6) 2017.

• Brand Name: ANTI-E (MONOCLONAL) GAMMA-CLONE
• Common Device Name: BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6835331
• Report Number: 1034569-2017-00245
• Device Sequence Number: 13469076
• Product Code: KSZ
• UDI-Device Identifier: 10888234001362
• UDI-Public: 10888234001362
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: 103639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 08/31/2017

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: Medical Technologist
• Device Expiration Date: 02/03/2019
• Device Catalogue Number: 0066422
• Device Lot Number: 954160
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR