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

Catalog Number	0414210
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported that they would send the sample out for workup at reference lab; no results or follow-up was provided to immucor.(b)(4).
Event or Problem Description
On (b)(6) 2021 a customer reported unexpected positive with anti-a,b in manual tube testing.

• Brand Name: GAMMA-CLONE ANTI-A,B (MONOCLONAL)
• Common Device Name: ANTI-A,B (MONOCLONAL) BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 11830124
• Report Number: 1034569-2021-00016
• Device Sequence Number: 17021714
• Product Code: QHR
• UDI-Device Identifier: 10888234001737
• UDI-Public: 10888234001737
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: 102130/0.0
• 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): 05/15/2021

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: 09/03/2021
• Device Catalogue Number: 0414210
• Device Lot Number: 304023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 DA