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

Catalog Number 0006406

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2017

Event Type  malfunction  

Manufacturer Narrative

Immucor technical support used a remote electronic connection method on 19sep2018 to assess the testing instrument test wells in question, which appeared as visually consistent with the instrument output.No errors were noted for the testing in question.The internal immucor record number is (b)(4).

Event Description

On (b)(6) 2018, a customer reported an unexpected positive result when using anti-b (murine monoclonal) series 3 on a galileo neo instrument, when tested on (b)(6) 2018.This led to an abo mistype.

• Brand Name: ANTI-B (MURINE MONOCLONAL) SERIES 3
• Type of Device: BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• Manufacturer (Section G): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• Manufacturer Contact: howard yorek ; 3130 gateway drive; norcross, GA 30091-5625 ; 7704412051
• MDR Report Key: 7967511
• MDR Text Key: 123825603
• Report Number: 1034569-2018-00228
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10888234000532
• UDI-Public: 10888234000532
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 102692/1009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 0006406
• Device Lot Number: 203761
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1