MAUDE Adverse Event Report: IMMUCOR, INC. PANOSCREEN I, II AND III; REAGENT RED BLOOD CELLS

Catalog Number	0002381
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is based on user error and reagent red blood cell exposure due to off-label use of the product by the customer.
Event or Problem Description
On (b)(6)2017, a customer site reported an unexpected user exposure to product.

• Brand Name: PANOSCREEN I, II AND III
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6797535
• Report Number: 1034569-2017-00206
• Device Sequence Number: 13844544
• Product Code: KSZ
• UDI-Device Identifier: 10888234000303
• UDI-Public: 10888234000303
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Medical Technologist
• Device Expiration Date: 05/19/2017
• Device Catalogue Number: 0002381
• Device Lot Number: 11997
• 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: 08/07/2017
• Initial Report FDA Received Date: 08/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR