MAUDE Adverse Event Report: IMMUCOR, INC. GAMMA-CLONE ANTI-C (MONOCLONAL) SERIES 2; ANTI-C (MONOCLONAL) BLOOD GROUPING REAGENT

Catalog Number	0066421
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On february 9, 2021 immucor confirmed reactivity of retention anti-c monoclonal lot 936210a with four heterozygous c antigen positive cells and four c antigen negative cells using retention panocell-20 lot 50556 and panocell-16 lot 02592.Controls performed as expected and all the c positive cells resulted as expected.Testing performed per package insert instructions.Retention product performed as expected.On february 11, 2021 immucor confirmed reactivity of return anti-c monoclonal lot 936210a with four heterozygous c antigen positive cells and four c antigen negative cells using retention panocell-20 lot 50556 and panocell-16 lot 02592.Controls performed as expected and all the c positive cells resulted as expected.Testing performed per package insert instructions.Return product performed as expected.On february 11, 2021 immucor tested return segments from unit w0352 21 11693600w with retention and return anti-c (monoclonal) gamma-clone lot 936210a.Controls performed as expected.The segment from unit w0352 21 11693600w tested negative with both retention and return anti-c (monoclonal) gamma-clone lot 936210a.The immucor internal record number for this report is (b)(4).
Event or Problem Description
On march 10, 2021 immucor became aware of an event involving an unexpected positive reaction for a unit from a donor who was historically negative for c antigen.

• Brand Name: GAMMA-CLONE ANTI-C (MONOCLONAL) SERIES 2
• Common Device Name: ANTI-C (MONOCLONAL) BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 11639337
• Report Number: 1034569-2021-00009
• Device Sequence Number: 14216094
• Product Code: QHR
• UDI-Device Identifier: 10888234001355
• UDI-Public: 10888234001355
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: 103498/5033
• 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): 04/08/2021

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: No Information
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: 0066421
• Device Lot Number: 936210-A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1