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

Model Number	03R89-62
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an eqa sample with an ethanol result of <0 mg/l.A rule within the aliniiq ams software was used to generate this result; however, this is not an expected result.The result below the limit of quantification should be reported as <100 mg/l.The ethanol results was incorrectly multiplied (x10) when results received from the instrument was <10.When results were received from instrument it was calculated and sent to lis as <0.The customer added an updated standard rule and tested manually, and it all worked fine.3 samples were tested and resulted in <100 mg/l, 1380 mg/l and 2710 mg/l.The last two were iqc samples and the results were approximately 10x the target values (measured in mg/dl, so this is correct).The first sample was water.The new rule appears to be working correctly.There is no report of impact to patient management at this time.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported an eqa sample with an ethanol result of <0 mg/l.A rule within the aliniiq ams software was used to generate this result; however, this is not an expected result.The result below the limit of quantification should be reported as <100 mg/l.The ethanol results was incorrectly multiplied (x10) when results received from the instrument was <10.When results were received from instrument it was calculated and sent to lis as <0.The customer added an updated standard rule and tested manually, and it all worked fine.3 samples were tested and resulted in <100 mg/l, 1380 mg/l and 2710 mg/l.The last two were iqc samples and the results were approximately 10x the target values (measured in mg/dl, so this is correct).The first sample was water.The new rule appears to be working correctly.There is no report of impact to patient management at this time.
Additional Manufacturer Narrative
Technical investigations performed by the abbott specialist found the aliniq ams rule that was installed was different to the current standard rule (data element was different).The generation of incorrect test results by aliniq ams was due to a misalignment in the data element name in the rule code occurred during the recompilation and activation of the imported rules at the new production server in the customer environment for the aliniq ams upgrade.The ams rule was disabled and replaced by a standard library and was successfully tested by the customer.The aliniq ams verification check of correctness completion of upgrade was successfully performed and documented.The configuration error caused by data elements names misalignment in the specific library was not detected during the verification because the cases when the specific situation occurs is rare.The incorrect alc test results released by the middleware to lis was due to a combination of multiple factors: compilation of the unexpected library code during the aliniq ams upgrade.A rare case which lead to this mismatch was not considered during the aliniq ams verification before go live after the upgrade.Before the upgrade the library with the correct code was active and aliniq ams v2.06 transmitted correct test results.Trending review determined no trends for the issue for the product.Device history record review did not show any nonconformances or potential non-conformances related to the issue described in the current complaint.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency with the aliniq ams was identified.

• 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: 16145727
• Report Number: 3004032053-2023-00001
• Device Sequence Number: 5743331
• Product Code: JQP
• UDI-Device Identifier: 00380740200169
• UDI-Public: 00380740200169
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/09/2023

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: OCE00918
• 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: 12/21/2022
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 05/09/2023
• 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