MAUDE Adverse Event Report: IMMUCOR, INC. PANOSCREEN I AND II - 2 VIAL SET; REAGENT RED BLOOD CELLS

Catalog Number	0002380
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The immucor laboratory did not test the retention product because it performed at the customer site as expected by another method.Reagent use by other method as expected.
Event or Problem Description
On (b)(6) 2016, a customer site reported unexpected negative antibody screens when using panoscreen i and ii - 2 vial set by test tube method.

• Brand Name: PANOSCREEN I AND II - 2 VIAL SET
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 5805476
• Report Number: 1034569-2016-00169
• Device Sequence Number: 13573525
• Product Code: KSZ
• UDI-Device Identifier: 10888234000297
• UDI-Public: 10888234000297
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: 102707
• 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): 07/19/2016

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: 07/29/2016
• Device Catalogue Number: 0002380
• Device Lot Number: 21819
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2016
• Initial Report FDA Received Date: 07/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR