MAUDE Adverse Event Report: IMMUCOR, INC. PANOCELL 20; REAGENT RED BLOOD CELLS

Catalog Number	0005020
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2020 immucor reviewed the donor records for this lot of panocell 20.Donor (b)(6) is listed as cell 20 on the master list for panocell 20 lot number 38456 (expiry november 27, 2020).In the special antigen column, this donor is documented as v+, vs+.On the back of the mater list, the supplemental unconfirmed typings documents this donor was v+, vs+ and discloses that this donor has been dna typed.In immucor's blood donor management system, it is documented that this is the first donation for donor (b)(6).This donor is documented as having been dna analyzed by hea beadchip.The donor has been genetically confirmed as v+, vs+.The immucor internal record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2020 a customer reported two patient samples unexpectedly not reacting to anti-v on panocell 20.

• Brand Name: PANOCELL 20
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• MDR Report Key: 11114017
• Report Number: 1034569-2021-00001
• Device Sequence Number: 11749850
• Product Code: QHT
• UDI-Device Identifier: 10888234001843
• UDI-Public: 10888234001843
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BL 102707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2021

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: Health Professional
• Device Expiration Date: 11/27/2020
• Device Catalogue Number: 0005020
• Device Lot Number: 38456
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1