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

Model Number	IMMULINK VERSION 2.2.0.17
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 a customer in new zealand reported that immulink transmitted the incorrect result to the lis.Customer reports that they have an lis system that recycles/reuses sample identifiers (sample code) for the barcodes on the specimen tubes.
Additional Manufacturer Narrative
The main cause is the reuse of sample identification for multiple patients.This is an lis design decision, as immucor has no control over the sample barcodes used to identify samples.Immulink has a feature intended to allow for the reuse of sample barcodes, in which a reused sample barcode id should be treated as a new sample.Immulink gives the newer sample a new internal sample identifier to manage the results separately.In the release of immulink version 2.2, an update to result processing was made to improve performance.During this update, an inadvertent change was made that impacted the duplicate sample barcode feature where immulink is failing to upload the results to the correct internal assigned id and if auto-export is enabled, the incorrect result can be sent.The specific configuration is provided below.The issue is limited to the 2.2.0.17 release of immulink and the customer configuration must include both of the following: 1.Customer must be reusing sample barcode identifier.2.Immulink must be configured to auto-export.For example, if immulink is not configured to auto-export, there will be no transmission from immulink with the wrong result information.We are only aware of the (b)(6) customer configured in this manner.We do have a few customers where sample identifiers are reused, but auto-export is not enabled for those customers.Immucor has developed a patch and we are working on releasing.Our plan is to update all 2.2.0.17 customers with the patch.The internal immucor reference for this event is (b)(4).

• Brand Name: IMMULINK
• Common Device Name: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• Manufacturer (Section G): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• Manufacturer Contact: howard yorek ; 3130 gateway drive; po box 5625; norcross, GA 30091-5625 ; 6784184738
• MDR Report Key: 15499780
• Report Number: 1034569-2022-00014
• Device Sequence Number: 20356029
• Product Code: MMH
• UDI-Device Identifier: 10888234001034
• UDI-Public: 10888234001034
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: BK150333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2022

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: Health Professional
• Device Model Number: IMMULINK VERSION 2.2.0.17
• Device Catalogue Number: 0064336
• Device Lot Number: 119584
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown