MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-B (MURINE MONOCLONAL) SERIES 3; BLOOD GROUPING REAGENT

Catalog Number	0006406
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The immucor laboratory tested retention product 03aug2017, which performed as expected.The immucor laboratory also tested returned blood sample from the customer site on (b)(6) 2017 by galileo method, which unexpectedly resulted negative with the anti-b test well.The immucor laboratory also tested returned blood sample from the customer site on (b)(6) 2017 by manual test tube method, which unexpectedly resulted negative with the anti-b test tube.Therefore, the immucor laboratory was able to reproduce the customer's issue.
Event or Problem Description
On 29jul2017, a customer reported an unexpected negative result when using anti-b (murine monoclonal) series 3 on a galileo instrument, when tested on (b)(6) 2017.

• Brand Name: ANTI-B (MURINE MONOCLONAL) SERIES 3
• Common Device Name: BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6795473
• Report Number: 1034569-2017-00203
• Device Sequence Number: 1571150
• Product Code: KSZ
• UDI-Device Identifier: 10888234000532
• UDI-Public: 10888234000532
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: 102692/1009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 08/15/2017

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: 12/07/2018
• Device Catalogue Number: 0006406
• Device Lot Number: 203681
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2017
• Initial Report FDA Received Date: 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1