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

Catalog Number	0002381
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The immucor laboratory tested retention product on (b)(6) 2018 which performed as expected.Immucor technical support used a remote electronic connection method to assess the galileo echo instrument, used for the supplemental testing, on (b)(6) 2018.All of the expected (b)(6) test wells appeared as visually (b)(6), and the camera report was optimal.The internal immucor record tracking number is (b)(4).
Event or Problem Description
On (b)(6) 2018, a customer site reported an unexpectedly negative antibody screen using panoscreen, when tested on (b)(6) 2018.

• 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: 8023965
• Report Number: 1034569-2018-00242
• Device Sequence Number: 11114524
• Product Code: KSZ
• UDI-Device Identifier: 10888234000303
• UDI-Public: 10888234000303
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

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: No Information
• Device Expiration Date: 10/05/2018
• Device Catalogue Number: 0002381
• Device Lot Number: 31423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 YR