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

Model Number	03R89-21
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed discrepant ferritin results reported on aliniq ams software for several patients.The abbott field service representative (fsr) configured wrong assay code 1460 for ferritin assay by the mistake, however later, the fsr corrected the ferritin assay code 61 configuration.The customer sent out corrected ferritin results to patients.No further impact to patient management.
Additional Manufacturer Narrative
A search of complaints identified three complaints similar to the event described in the current complaint.No inadequate patient treatments or adverse impacts on patients¿ health were reported by the customer due to this error.The issue was resolved through a configuration change within the aliniq ams, version 2.08 1+, settings at the customer site: ferritin test-channel configuration was fixed on both architect instruments so that correct values were sent from instrument to aliniq ams.A review of the labeling addresses the customer¿s issue: configurator user manual, rev.: 1 - product suite: 2.08 provides appropriate information on configuring the test-channel codes.A review of tracking and trending did not identify any trends for the complaint issue.Additionally, labeling was reviewed and was found to adequately address the issue under review.Based on this information a deficiency was not identified for the aliniq ams middleware v2.08 1+.

• Brand Name: ALINIQ AMS
• Common Device Name: 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: 15562909
• Report Number: 3004032053-2022-00006
• Device Sequence Number: 12183658
• Product Code: JQP
• UDI-Device Identifier: 00380740158255
• UDI-Public: 00380740158255
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: 03R89-21
• Device Catalogue Number: 03R89-21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 10/20/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown