MAUDE Adverse Event Report: IMMUCOR, INC. IMMULINK; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Catalog Number 0064330

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

On june 26, 2019 immucor service engineers determined that immulink was mapped incorrectly causing the discrepant interpretation; the mapping problem was corrected at that time.Mapping is part of the customizable configuration that occurs during installation; the mapping is validated by the customer as being correct as part of the initial software installation.After installation, the customer does not have permissions to alter the mapping.Customer was notified of the findings and that the issue had been corrected.(b)(4).

Event Description

On (b)(6) 2019 a customer complained that immulink had reported an incorrect interpretation for a donor confirm (forward abo and rh); an ab positive sample was correctly interpreted on the neo analyzer but the result in immulink was displayed a positive.

• Brand Name: IMMULINK
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• 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: 8768362
• MDR Text Key: 151473367
• Report Number: 1034569-2019-00112
• Device Sequence Number: 1
• Product Code: MMH
• UDI-Device Identifier: 10888234001034
• UDI-Public: 10888234001034
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 0064330
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2009
• 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