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

Catalog Number	0066421
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on 17dec2017 to assess the instrument test well image in question, which appeared as visually negative, with a couple of tiny red/black particles in the well.The immucor laboratory tested retention product 20dec2017, which performed as expected.The immucor laboratory also tested a returned blood sample from the customer site on (b)(6) 2017 which generated an equivocal outcome with instrument testing, and also weak positive with alternative manual test tube testing, with the same lot of reagent in question.
Event or Problem Description
On (b)(6) 2017, an immucor employee at a customer site reported, on behalf of the customer, an unexpected negative result when using anti-c (monoclonal) gamma-clone by galileo echo instrument method, when tested on (b)(6) 2017.

• Brand Name: ANTI-C (MONOCLONAL) GAMMA-CLONE
• Common Device Name: BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 7175530
• Report Number: 1034569-2018-00008
• Device Sequence Number: 11250801
• Product Code: KSZ
• UDI-Device Identifier: 10888234001355
• UDI-Public: 10888234001355
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 103498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2018

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: Medical Technologist
• Device Expiration Date: 05/15/2019
• Device Catalogue Number: 0066421
• Device Lot Number: 936170
• 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: 12/15/2017
• Initial Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1