MAUDE Adverse Event Report: IMMUCOR, INC. PANOSCREEN I, II AND III - 3 VIAL SET; REAGENT RED BLOOD CELLS

Catalog Number	0002381
Medical Device Problem Code	Inadequate or Insufficient Training (1643)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support interviewed the user at the customer site on (b)(6) 2019 about the event.(b)(4).
Event or Problem Description
On (b)(6) 2019, a user at a customer site reported an accidental exposure to reagent red blood cells.

• Brand Name: PANOSCREEN I, II AND III - 3 VIAL SET
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8416848
• Report Number: 1034569-2019-00056
• Device Sequence Number: 1278386
• Product Code: KSZ
• UDI-Device Identifier: 10888234000303
• UDI-Public: 10888234000303
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 0002381
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2019
• Initial Report FDA Received Date: 03/13/2019
• 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: 26 YR