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

Catalog Number	03R89-62
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
Updated postal code e1=to (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed cerebrospinal fluid albumin dilution results did not transferred to lis by alniq ams software which connected to alinity c processing module.The initial cerebrospinal fluid albumin result 500 generated, and auto dilution performed correctly by the alinity c processing module.The customer determined the issue when the ams software transmitted 500 initial patient result to lis for cerebrospinal fluid albumin and did not hold for rerun and reported 500 from lis.During the site visit the abbott fsr did not setup the requested rule by the customer.The customer requested to setup rule to hold 500 cerebrospinal fluid albumin results for dilution after installation, however, the customer wrote the incorrect information to hold when cerebrospinal fluid albumin results 500 instead of 500.After the incident, the customer updated for repeat testing rule scenarios for cerebrospinal fluid albumin to be blocked and diluted if result is 500.00.The abbott fsr configurated the rule as per customer requested and validated by the customer.No adverse impact to patient management was reported.
Event or Problem Description
The customer observed cerebrospinal fluid albumin dilution results did not transferred to lis by alniq ams software which connected to alinity c processing module.The initial cerebrospinal fluid albumin result >500 generated, and auto dilution performed correctly by the alinity c processing module.The customer determined the issue when the ams software transmitted >500 initial patient result to lis for cerebrospinal fluid albumin and did not hold for rerun and reported >500 from lis.During the site visit the abbott fsr did not setup the requested rule by the customer.The customer requested to setup rule to hold >500 cerebrospinal fluid albumin results for dilution after installation, however, the customer wrote the incorrect information to hold when cerebrospinal fluid albumin results < 500 instead of > 500.After the incident, the customer updated for repeat testing rule scenarios for cerebrospinal fluid albumin to be blocked and diluted if result is > 500.00.The abbott fsr configurated the rule as per customer requested and validated by the customer.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation performed by the aliniq ams technical group for inconsistency of test results released by the aliniq ams software included a review of data and information provided by the customer, search for similar complaints, ticket trending review, and labeling review.A review of labeling and historical data was done, and both were adequate, with no trends found.The investigation indicated that the issue was due during the site installation and configuration phase the customer did not request any specific rule intended to block and rerun with dilution in the middleware if a cerebrospinal fluid albumin result > 500.00 is received from the analyzer.Consequently, the >500 results, was automatically validated and sent to the lis by the middleware according to the configurations in the middleware requested and approved by the customer.In order to satisfy customer¿ expected workflow for cerebrospinal fluid albumin test having a rerun with dilution and block the cerebrospinal fluid albumin if the result received from the alinity c instrument is starting by ¿>¿ (meaning, > 500.00 linearity limit), the local its added a row in the standard rule template (library name: qlib03_lnr_hl_mlt, template name: t_linearityh).The rule requirements were agreed upon with the customer and the configuration was activated by the abbott informatics technical specialist on (b)(6) 2023.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency of aliniq ams middleware, version 3.01, 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: 17711043
• Report Number: 3004032053-2023-00023
• Device Sequence Number: 2236284
• Product Code: JQP
• UDI-Device Identifier: 00380740200169
• UDI-Public: 00380740200169
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 12/21/2023

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 Catalogue Number: 03R89-62
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 12/21/2023
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown