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

Catalog Number	00420503
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Product notification issued 04/16/2020 for gamma-clone anti-d (monoclonal blend) blood grouping reagent, lots 506300, 506301 regarding decrease in product potency.

• Brand Name: GAMMA-CLONE
• Common Device Name: ANTI-D (MONOCLONAL BLEND) BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross, ga
• MDR Report Key: 9981711
• Report Number: 1034569-2020-00024
• Device Sequence Number: 14563419
• Product Code: QHR
• UDI-Device Identifier: 10888234001348
• UDI-Public: 10888234001348
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: BL 103523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/21/2020

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: Health Professional
• Device Expiration Date: 06/03/2021
• Device Catalogue Number: 00420503
• Device Lot Number: 506301
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1