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	10/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on (b)(6) 2016 to assess the test well images in question and determined that the forward antigen test well was visually positive, and the reverse typing test well in question visually showed an unexpected negative reaction, which was consistent with the overall erroneous instrument abo blood type output.The immucor laboratory tested retention product on (b)(6) 2016, which performed as expected.The immucor laboratory also tested a blood sample that had been returned from the customer site on (b)(6) 2016 which tested as an expected abo type a outcome.This returned blood sample was also tested against the retention lot of the anti-b, and an expected negative outcome was obtained.The immucor laboratory could not reproduce the customer's site testing outcome.
Event or Problem Description
On (b)(6) 2016, a customer reported an unexpected negative result when using anti-b (murine monoclonal) series 3 on a galileo instrument.

• 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: 6099323
• Report Number: 1034569-2016-00293
• Device Sequence Number: 13745474
• 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): 11/14/2016

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: 02/17/2018
• Device Catalogue Number: 0006406
• Device Lot Number: 203640
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2016
• Initial Report FDA Received Date: 11/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1