MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN 3; REAGENT RED BLOOD CELLS

Catalog Number	0066813
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On march 19, 2021 immucor reviewed manufacturing and complaint records for capture-r ready-screen 3 lot number r205 and found no deviations or complaint trends.On march 31, 2021 immucor technical service advised the customer of the limitation "weak examples of other clinically relevant antibodies, such a passively administered anti-d, may fail to react by capture-r ready-id, even though the antibodies are detected by an alternative technique." from capture r package insert.The immucor internal record number for this report is (b)(4).
Event or Problem Description
On march 12, 2021 a customer reported an unexpected negative antibody screen result with capture-r ready-screen 3 lot number r205 on echo lumena instrument serial number (b)(4).

• Brand Name: CAPTURE-R READY-SCREEN 3
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 11632189
• Report Number: 1034569-2021-00008
• Device Sequence Number: 3495972
• Product Code: KSZ
• UDI-Device Identifier: 10888234001454
• UDI-Public: 10888234001454
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 102707/5045
• 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): 04/07/2021

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 Expiration Date: 03/02/2021
• Device Catalogue Number: 0066813
• Device Lot Number: R205
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 53