MAUDE Adverse Event Report: IMMUCOR, INC. REFERENCELLS - 2 (GROUP A1 AND B); REAGENT RED BLOOD CELLS

Catalog Number	0002345
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An immucor field service engineer (fse) visited the customer site on (b)(6) 2018, to assess the testing instrument in question, and the fse determined that the instrument was operating as expected.The fse also collected instrument software test well image data for immucor technical support to assess, which showed the test well images to be consistent with the overall instrument output.
Event or Problem Description
On (b)(6) 2018, a customer site reported an unexpected abo mistype by galileo instrument method, when tested on (b)(6) 2018.

• Brand Name: REFERENCELLS - 2 (GROUP A1 AND B)
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 7553990
• Report Number: 1034569-2018-00131
• Device Sequence Number: 19147713
• Product Code: KSZ
• UDI-Device Identifier: 10888234000273
• UDI-Public: 10888234000273
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 05/30/2018

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: 05/11/2018
• Device Catalogue Number: 0002345
• Device Lot Number: 110360
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1