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

Catalog Number 0006400

Device Problem False Positive Result (1227)

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

Event Date 10/07/2018

Event Type  malfunction  

Manufacturer Narrative

Immucor technical support used a remote electronic connection method on (b)(4) 2018 to assess the instrument used for testing, and determined that there were no errors found on the event log during processing, the rois were as expected and that the flatfield was found to be clean.The internal immucor tracking number for this record is (b)(4).

Event Description

On (b)(6) 2018, a customer site reported an unexpectedly positive instrument result when using anti-a (murine monoclonal) series 1 by galileo neo, which led to an abo mistype on (b)(6) 2018.

• Brand Name: ANTI-A (MURINE MONOCLONAL) SERIES 1
• 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: 8025974
• MDR Text Key: 127248686
• Report Number: 1034569-2018-00245
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10888234000525
• UDI-Public: 10888234000525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 102691/0.0
• 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: 10/31/2018

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
• Device Operator: No Information
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 0006400
• Device Lot Number: 101885
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2018
• 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