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

Catalog Number	0064330
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8768362
• Report Number: 1034569-2019-00112
• Device Sequence Number: 11397992
• Product Code: MMH
• UDI-Device Identifier: 10888234001034
• UDI-Public: 10888234001034
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: BK150333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Catalogue Number: 0064330
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1