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	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method, both on 17apr2018 and 19apr2018, to assess the instrument testing well images in question which appeared visually negative.Additionally, there were no errors in the instrument software event logs, and the rois were centered.An immucor field service engineer (fse) visited the customer site on 28apr2018, to assess the testing instrument, and subsequently replaced the discolored syringes, and also proactively replaced the lld board because it was discolored also.(b)(4).
Event or Problem Description
On 17apr2018, a (b)(6) customer reported an unexpected negative result when using anti-c (monoclonal) gamma-clone by galileo neo instrument method, when tested on (b)(6) 2018.

• 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: 7503044
• Report Number: 1034569-2018-00116
• Device Sequence Number: 16557099
• Product Code: KSZ
• UDI-Device Identifier: 10888234001355
• UDI-Public: 10888234001355
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 103498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 05/10/2018

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: 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: 04/17/2018
• Initial Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1