MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-A (MURINE MONOCLONAL) SERIES 1; BLOOD GROUPING REAGENT

Catalog Number	0006400
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The immucor laboratory tested retention product on (b)(6)2017, which performed as expected.
Event or Problem Description
On (b)(4)2017, a customer site reported an unexpected negative well result when using anti-a (murine monoclonal) series 1 on a galileo instrument, when tested on (b)(6)2017, which led to an abo mistype.

• Brand Name: ANTI-A (MURINE MONOCLONAL) SERIES 1
• Common Device Name: BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6795819
• Report Number: 1034569-2017-00205
• Device Sequence Number: 1236545
• Product Code: KSZ
• UDI-Device Identifier: 10888234000525
• UDI-Public: 10888234000525
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: 102691/0.0
• 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: 12/19/2018
• Device Catalogue Number: 0006400
• Device Lot Number: 101815
• 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: 08/01/2017
• 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