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

Catalog Number 03R89-62

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer observed transferring incorrect results from panel t25 to the new created t218 panel on ams aniq software which connected to non-abbott phadia1000 analyzer.The customer has two allergy panel for different allergy testing named t25 and t218 on non-abbott phadia1000 analyzer.The new prime t218 panel configured by the abbott fsr.The abbott fsr configured incorrect channels which used for panel t25, so all results from t25 panel transferring to t218 panel.The customer noticed incorrect results for t218 panel coming to lis and stopped sending those results.There were no incorrect results reported out of the laboratory.The results provided were: sid (b)(6): 45yrs old male: t218=< 0.10 /repeated=<0.10.Sid (b)(6): 65yrs old female: t218=< 0.10 /repeated=<0.10.Sid (b)(6): 10yrs old female: t218=>100 /repeated=0.49 there was no reported impact to patient management.

Manufacturer Narrative

Complete information for section a patient information, 1.Patient identifier = sid= (b)(6),(b)(6),(b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed transferring incorrect results from panel t25 to the new created t218 panel on ams aniq software which connected to non-abbott phadia1000 analyzer.The customer has two allergy panel for different allergy testing named t25 and t218 on non-abbott phadia1000 analyzer.The new prime t218 panel configured by the abbott fsr.The abbott fsr configured incorrect channels which used for panel t25, so all results from t25 panel transferring to t218 panel.The customer noticed incorrect results for t218 panel coming to lis and stopped sending those results.There were no incorrect results reported out of the laboratory.The results provided were: sid (b)(6): 45yrs old male: t218=< 0.10 /repeated=<0.10 sid (b)(6): 65yrs old female: t218=< 0.10 /repeated=<0.10 sid (b)(6): 10yrs old female: t218=>100 /repeated=0.49 there was no reported impact to patient management.

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 to human error performed during the creation of a new non-abbott test asked by customer.The channel code was set up incorrectly on the middleware: the t218 panel was configured with the upload assay code of another allergen test (t25) specimen, causing the wrong association of the test results in aliniq ams.During the verification of the new test configuration, the test mismatch was not detected by the abbott informatic technical specialist because of the very similar results ranges returned by the instrument.The issue was resolved through a configuration change within the aliniq ams middleware settings at the customer site performed by the abbott informatics technical specialist: the channel code of the t218 test was properly associated in the analyzer section on aliniq ams so that correct values were released by aliniq ams and sent to the lis.A review of the labeling addresses the customer¿s issue: the ams configurator user manual 3.01 provides adequate information how to configure the test-channel codes used by the windows services managing communications with the analyzer.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.No inadequate patient treatments or adverse impacts on patients¿ health were reported by the customer due to this 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.Updated information in section g1:.

• Brand Name: ALINIQ AMS
• Type of Device: 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: 17871725
• MDR Text Key: 324934053
• Report Number: 3004032053-2023-00024
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 03R89-62
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1