MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-IGG, C3D; ANTI-HUMAN GLOBULIN (MURINE MONOCLONAL)

Catalog Number	0401010
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2020 immucor performed antibody screens by tube method using 4 known antibody negative in house donors with retention panoscreen iii lot 30003, retention peg lot 336041 as enhancement, and retention anti-igg,-c3d clear lot 703021 for ahg phase.Controls performed as expected, and all in house donor samples resulted negative as expected.All tubes were checked at the ahg phase using retention checkcells lot 34423.All tubes reacted 3+.Lot 703021 performed as expected.Retention product performed as expected.On october 23, 2020 immucor performed additional review of the complaint and determined that an assessment for reporting was appropriate.
Event or Problem Description
On (b)(6) 2020 a customer received unexpected (b)(6) reactions with anti-igg, c3d.

• Brand Name: ANTI-IGG, C3D
• Common Device Name: ANTI-HUMAN GLOBULIN (MURINE MONOCLONAL)
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 10805618
• Report Number: 1034569-2020-00059
• Device Sequence Number: 2863856
• Product Code: QHS
• UDI-Device Identifier: 10888234001638
• UDI-Public: 10888234001638
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: BL103003/0.0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2020

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: 07/22/2021
• Device Catalogue Number: 0401010
• Device Lot Number: 703021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1