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

Model Number	03R89-48
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 ams aliniq software did not hold the 0.90 s/co syphilis result till alinity s processing module performed duplicate repeat run for grayzone range.The customer has grayzone range setup 0.90 to 1.00 s/co in alinity s processing module.Those grayzone results need to be repeated in duplicate on alinity s processing module before reported to lis.The ams has configured range > 0.90 s/co for syphilis.The ams software did not hold results if exact results 0.90 s/co.There was range setting discrepancy between alinity s processing module and ams software.The abbott fsr configured the range in ams software =0.90 s/co to 1.00 s/co for hold all those screen assay hiv, hcv, syphilis and hbv till duplicate runs performed.There was no information provided by the customer for discrepant results reported to provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
The abbott specialist performed technical investigations, revealed that the root cause of the unexpected auto validation of the serological test result and transmission to the lis while the test was still being rerun in the instrument was a misalignment of cutoff and range setting between the alinity s and aliniq ams where the interval values configured in the middleware by the abbott informatic specialist were provided and accepted by the customer.The gray zone range was setup from 0.90 to 1.00 s/co in alinity s while in the middleware exact lower value of 0.90 s/co was considered as a normal value and then, it was not held till duplicate runs were performed on the analyzer before reported to the lis.The 12 months search reports did not identify complaints similar to the issue described in the current one.An aliniq ams configuration change was performed to meet customer needs: on (b)(6) 2023, a modification to the reference range values was performed by the abbott technician to include 0.9 results in the gray zone for holding in aliniq ams.The attention value was moved from 0.9 to 0.89 s/co so that, in the case where a 0.9 result is reported by the instrument, the new configuration would permit the value to be considered in the gray zone and blocked consequently as per the customer request and the parallel configuration on the instrument.A review of the labeling addresses the customer¿s issue: configurator user manual rev.: 0 - product suite: 2.12 provides adequate information about how to configure the reference ranges (section 2.19.1.8 reference values) and validation method in the analyzer section in aliniq ams (section 2.9.2.5 general setup).Based on the investigation the aliniq ams is performing as intended, no systemic issue or deficiency of the aliniq ams was identified.
Event or Problem Description
The customer observed ams aliniq software did not hold the 0.90 s/co syphilis result till alinity s processing module performed duplicate repeat run for grayzone range.The customer has grayzone range setup 0.90 to 1.00 s/co in alinity s processing module.Those grayzone results need to be repeated in duplicate on alinity s processing module before reported to lis.The ams has configured range > 0.90 s/co for syphilis.The ams software did not hold results if exact results 0.90 s/co.There was range setting discrepancy between alinity s processing module and ams software.The abbott fsr configured the range in ams software =0.90 s/co to 1.00 s/co for hold all those screen assay hiv, hcv, syphilis and hbv till duplicate runs performed.There was no information provided by the customer for discrepant results reported to provider.There was no reported impact to patient management.

• 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: 16778058
• Report Number: 3004032053-2023-00015
• Device Sequence Number: 17810033
• Product Code: JQP
• UDI-Device Identifier: 00380740189914
• UDI-Public: 00380740189914
• 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): 06/23/2023

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: 03R89-48
• Device Catalogue Number: 03R89-48
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2020
• 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