MAUDE Adverse Event Report: ABBOTT SRL ALINIQ AMS; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number 03R89-47

Device Problem Computer Software Problem (1112)

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

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.No specific patient information was provided.

Event Description

The customer reported the incorrect assay was ran while using the aliniq ams software.Sample id: (b)(6) generated a folate result of 101.71 from an analyzer that did not have a folate reagent installed.The result was actually ferritin and not the ordered folate.Review of the incident found the mapping of the aliniq ams had a configuration error in which the folate test was configured with the ferritin assay code.Additionally, a similar error was identified for the urine total protein which had the assay code for urine phosphatase.A look back was performed, and 170 folate patient results were impacted and 31 urine total protein results were impacted.To date, there has been no report of adverse impact to patient management.

Manufacturer Narrative

H6 conclusion code: 4316: issue caused by configuration error by a company representative.The investigation performed by the aliniq ams technical group indicated that the unexpected behavior of the middleware was due to an incorrect configuration of the test-channel association in the analyzer section performed during the system installation and configuration phase.Inconsistency of test results between the middleware and the abbott instrument (alinity ci) was due to a misconfiguration of the folates assay code that was configured using the ferritin assay code instead.The aliniq ams mapping had the same incorrect test-channel association for urine miction total protein (umpt) which had the assay code for urine miction phosphatase (ump).The issue was resolved through a configuration change within the aliniq ams middleware settings at the customer site: channel codes of the folates (fol) and urine miction total protein (umpt) tests were properly associated in the analyzer section on the middleware.Review of complaint activity and trending data did not identify any issues.The aliniq ams configurator user manual 2.11 provides labelling information on configuration the test channel codes.Based on the available information and this investigation, no systemic issue or deficiency of the aliniq ams, version 2.11 was identified.

Event Description

The customer reported the incorrect assay was ran while using the aliniq ams software.Sample id (b)(6) generated a folate result of 101.71 from an analyzer that did not have a folate reagent installed.The result was actually ferritin and not the ordered folate.Review of the incident found the mapping of the aliniq ams had a configuration error in which the folate test was configured with the ferritin assay code.Additionally, a similar error was identified for the urine total protein which had the assay code for urine phosphatase.A look back was performed and 170 folate patient results were impacted and 31 urine total protein results were impacted.To date there has been no report of adverse impact to patient management.

• Brand Name: ALINIQ AMS
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT SRL; via giorgio ribotta 9; rome 00144 ; IT 00144
• MDR Report Key: 11076190
• MDR Text Key: 223795122
• Report Number: 3004032053-2020-00006
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 00380740189907
• UDI-Public: 00380740189907
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

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: Health Professional
• Device Model Number: 03R89-47
• Device Catalogue Number: 03R89-47
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 12/28/2020
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1