MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-D (MONOCLONAL BLEND) SERIES 4; BLOOD GROUPING REAGENT

Catalog Number	0006412
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the sample was retested and resulted as expected, cannot rule out the initial vial may have been compromised causing the reported problem.
Event or Problem Description
On (b)(6) 2016 a customer reported unexpected positive (1+) weak d reactivity using anti-d (monoclonal blend) series 4 lot 504705 on an rh negative patient sample.No adverse event occurred due to the unexpected result.

• Brand Name: ANTI-D (MONOCLONAL BLEND) SERIES 4
• Common Device Name: BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 5805494
• Report Number: 1034569-2016-00162
• Device Sequence Number: 232313
• Product Code: KSZ
• UDI-Device Identifier: 10888234000556
• UDI-Public: 10888234000556
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: 103523/0.0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2016

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: Medical Technologist
• Device Expiration Date: 12/16/2017
• Device Catalogue Number: 0006412
• Device Lot Number: 504705
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2016
• Initial Report FDA Received Date: 07/19/2016
• 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