MAUDE Adverse Event Report: IMMUCOR, INC. GAMMACLONE ANTI-FYB (MONOCLONAL); BLOOD GROUPING REAGENT, ANTI-FYB (MONOCLONAL)

Catalog Number	0004818
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On june 9, 2021 incident was reported to immucor.Immucor queried customer and determined that there assay was performed according to label instructions.Anti-fyb reagent lot involved had already expired by this time and additional investigation was not possible.The immucor internal record number for this report is pr#(b)(4).
Event or Problem Description
On june 4, 2021 a customer received unexpected negative results with fyb assay on the manual platform.

• Brand Name: GAMMACLONE ANTI-FYB (MONOCLONAL)
• Common Device Name: BLOOD GROUPING REAGENT, ANTI-FYB (MONOCLONAL)
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• MDR Report Key: 12146794
• Report Number: 1034569-2021-00019
• Device Sequence Number: 17331480
• Product Code: QHR
• UDI-Device Identifier: 10888234002383
• UDI-Public: 10888234002383
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BL 125686
• 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): 07/09/2021

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: 06/07/2021
• Device Catalogue Number: 0004818
• Device Lot Number: 619040
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR