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

Catalog Number	03R89-63
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
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 reported that a retest was performed for the s-iga assay with a std 1:5 dilution when it should have processed the sample undiluted.The cause was the ams software was configured incorrectly to run as 1:undiluted, rerun without a dilution factor so the instrument ran the sample with the standard 1:5 dilution as this is the default for this assay.Due to the dilution the result was reported by ams was <0.250 and the lis removed the < character and released 0.250.The correct result was <0.050.There was no reported impact to patient management.
Additional Manufacturer Narrative
Section b5 was updated with: additional data provided on 13aug2024: customer states total of 5 patients impacted.Three patient results should have been <0.25 g/l and the lis released 0.25 g/l.One patient result was 0.258 g/l and lis released 0.25 g/l no correction needed.The fifth sample was disposed of and not repeated.The complaint investigation indicated that the cause of the issue was an incorrect configuration setup.The issue was corrected.A review of complaints for this issue was performed and no additional complaints were identified.A review of historical data revealed no trends, systemic issues, or related nonconformances for the complaint issue.Current labelling contained adequate information regarding the configuration of dilution factors and expected behavior of the middleware.Based on all available information and abbott¿s complaint investigation, no product deficiency was identified for the aliniq ams.
Event or Problem Description
The customer reported that a retest was performed for the s-iga assay with a std 1:5 dilution when it should have processed the sample undiluted.The cause was the ams software was configured incorrectly to run as 1: undiluted, rerun without a dilution factor so the instrument ran the sample with the standard 1:5 dilution as this is the default for this assay.Due to the dilution the result was reported by ams was <0.250 and the lis removed the < character and released 0.250.The correct result was <0.050.Additional data provided on 13aug2024: customer states total of 5 patients impacted.Three patient results should have been <0.25 g/l and the lis released 0.25 g/l.One patient result was 0.258 g/l and lis released 0.25 g/l no correction needed.The fifth sample was disposed of and not repeated.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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19723818
• Report Number: 3004032053-2024-00011
• Device Sequence Number: 8327825
• Product Code: JQP
• UDI-Device Identifier: 00380740202736
• UDI-Public: (01)00380740202736(10)3.02
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 08/22/2024

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 Catalogue Number: 03R89-63
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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