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

Model Number 03R89-48

Device Problems Computer Software Problem (1112); Installation-Related Problem (2965)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a software issue with the aliniq ams 2.12.The customer reported that hdl test orders sent by the lis were mismatched on the ams with the ldh test.The ams was configured for the hdl assay on (b)(6) 2022.The ams and alinity analyzer were connected to the lis on (b)(6) 2022 and only the hdl orders were affected from (b)(6).The ams configuration was modified on (b)(6) and the 241 samples with hdl orders were rerun to correct the results.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for hdl test results that were mismatched with ldh results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, and labeling review.A review of labeling and historical data was done, and both were adequate, with no trends found.The investigation 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.The inconsistency of test results between the middleware and the abbott instruments was due to a misconfiguration of the hdl assay code that was configured using the ldh assay code instead.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency of aliniq ams middleware, version 2.12, was identified.H6 medical device problem code updated from a20 to a11.

• 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
• Manufacturer (Section G): ABBOTT SRL; via giorgio ribotta 9; rome 00144 ; IT 00144
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 13978855
• MDR Text Key: 298223721
• Report Number: 3004032053-2022-00002
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 00380740189914
• UDI-Public: 00380740189914
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

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
• Device Operator: Health Professional
• Device Model Number: 03R89-48
• Device Catalogue Number: 03R89-48
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/08/2022
• Supplement Dates FDA Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1