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

Catalog Number	0006400
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The immucor laboratory tested retention product on (b)(6) 2018 which performed as expected.The internal immucor tracking number for this record is (b)(4).
Event or Problem Description
On (b)(6) 2018, a customer site reported an unexpectedly (b)(6) manual test tube result when using anti-a (murine monoclonal) series 1 by manual test tube, 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: 7722475
• Report Number: 1034569-2018-00173
• Device Sequence Number: 1076163
• Product Code: KSZ
• UDI-Device Identifier: 10888234000525
• UDI-Public: 10888234000525
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2018

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: No Information
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 0006400
• Device Lot Number: 101885
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1