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

Model Number	03R89-62
Medical Device Problem Codes	Problem with Software Installation (3013); Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed the ggt assay was configured incorrectly in the aliniq ams which then generated discrepant results.The customer was switching over to sigma strong reagents and an abbott representative reconfigured the aliniq ams to the new updated assay codes for ggt, got, fal, fe, ldh, chol, and trig.After the reconfiguration was completed, the customer observed unexpected ggt results that were held in the lis.No discrepant results were released from the laboratory.The aliniq ams was then reconfigured to the correct ggt assay code.No specific data or specific patient information was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The abbott specialist determined the inconsistency of test results between the middleware and the instruments was due to the incorrect data input received from the abbott application specialist that led to an incorrect test-channel association in aliniq ams.Because of a not very accurate excel sheet provided by the abbott application specialist to the abbott informatic specialist, containing the list of the tests to be changed and related transaction codes, ggt assay test code the channel codes of the alinity analyzers were set up incorrectly in aliniq ams.The upload/download channels of the gamma-glutamyl transpeptidase (ggt) test codes were misconfigured in aliniq ams with the alanine transaminase (alt) assay code causing the wrong association of the test results in aliniq ams.The issue was resolved through a configuration change within the aliniq ams, version 3.01, settings at the customer site: ggt test-channel configuration was fixed on all the four alinity ci instruments so that correct values were sent from instrument to aliniq ams and release to lis.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation no systemic issue or deficiency with the aliniq ams was identified.After further review, section h6 medical device problem code was updated form a110702 to a110207 and component code was updated from g00301 to g02008.
Event or Problem Description
The customer observed the ggt assay was configured incorrectly in the aliniq ams which then generated discrepant results.The customer was switching over to sigma strong reagents and an abbott representative reconfigured the aliniq ams to the new updated assay codes for ggt, got, fal, fe, ldh, chol, and trig.After the reconfiguration was completed, the customer observed unexpected ggt results that were held in the lis.No discrepant results were released from the laboratory.The aliniq ams was then reconfigured to the correct ggt assay code.No specific data or specific patient information was provided.No impact to patient management was reported.

• 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: 16710715
• Report Number: 3004032053-2023-00012
• Device Sequence Number: 7274516
• Product Code: JQP
• UDI-Device Identifier: 00380740200169
• UDI-Public: 00380740200169
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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: 03R89-62
• Device Catalogue Number: 03R89-62
• Device Lot Number: UNKNOWN
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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