MAUDE Adverse Event Report: IMMUCOR, INC. TPHA SCREEN TEST CELLS; FOR THE DETECTION OF ANTIBODIES TO TREPONEMA PALLIDUM

Catalog Number	0066826
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support assessed the test well images on the testing instrument using a remote electronic connection method on (b)(6) 2016.The test wells were visually negative.The immucor laboratory tested retention product on (b)(6) 2016, which performed as expected.Additional testing was performed using the research use only seracare panel, which yielded inconsistent results, which reproduced the customer's observation.
Event or Problem Description
On (b)(6) 2016, a customer reported unexpected negative outcomes when validating an instrument assay for tpha assay, using tpha screen test cells on a galileo neo.

• Brand Name: TPHA SCREEN TEST CELLS
• Common Device Name: FOR THE DETECTION OF ANTIBODIES TO TREPONEMA PALLIDUM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 5971028
• Report Number: 1034569-2016-00248
• Device Sequence Number: 1625914
• Product Code: MYR
• UDI-Device Identifier: 10888234001485
• UDI-Public: 10888234001485
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK120021
• 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): 09/22/2016

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: 03/30/2017
• Device Catalogue Number: 0066826
• Device Lot Number: 280006
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2016
• Initial Report FDA Received Date: 09/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1