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

Catalog Number 03R89-24

Device Problem Computer Software Problem (1112)

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

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed mismatched results that were automatically validated on aliniq software version v2.10.There was a reversal of results between the psa, total and psa, free assay.A qpl result of 1.003 for psa, total was automatically validated even though it did not correspond to any results output from the machine.It was determined that there was an error in the configuration rules that was immediately identified by an abbott employee and corrected.No impact to patient management was reported.

Manufacturer Narrative

Technical investigations were conducted, and it was found that there is a rule (hil_3) requested and agreed with the customer and running since (b)(6) 2023, on aliniq ams that is intended to manage hil (hemolysis, icterus, lipemia) results.The hil_3 rule (this is an onreceiveresult rule because it triggers whenever ams receives a test result sent by the analyzer) deletes all results received from the instrument before those of the h, i and l indices and saves them in a specific test (com_hil) comment to reintegrate them, later, when the last result of the indices is received.The logic of this part of the rule was looking for the set of string ¿psa¿ using the function ¿pos¿ in a ¿while¿ loop in the ¿com_hil¿ test comment that contained the results for both ¿psa¿ and ¿psal¿, in this order.This caused the rule to find first the result of ¿psa¿ then that of the ¿psal¿ thus, overwriting the first with the latter.As both results for ¿psa¿ and ¿psal¿ tests came before those of the h, i and l indices leading to the psa results were overwritten with the psal value.The incorrect automatic validation and release of incorrect psa results was due to combination of factors (human errors): - during the evaluation of the hil_3 rule logic and its implementation, the abbott informatics technical specialist did not properly evaluate the sequence of events and conditions in the psa and psal workflow.- as ¿psa¿ and ¿psal¿ tests came before the h, i and l indices and the ¿com_hil¿ test comment contained the results for both ¿psa¿ and ¿psal¿, in this order, the rule found first the result of ¿psa¿ then the one of the ¿psal¿ thus leading to the overwriting of the first results received with the latter; - the rule verification performed before the activation, was not accurately performed by the abbott informatics technical specialist as the overwritten of psa results with psal values was not detected; - customer validated (as per defined responsibilities) the rule not discovering the issue.To fix this scenario the customer requested to have hil indices managed into the lis and not in aliniq ams.Aliniq ams hil rules were disabled by the local abbott informatic technical specialist on (b)(6) 2024 so that results could not be wrongly overwritten.A retrospective review was conducted to identify similar situation where psa results was changed replacing with the result of the psal test and then auto validated and released to the lis.It was found that, from (b)(6) 2023 (date of activation of the hil_3 rule) to (b)(6) 2024 (date of rule disabling) 8 additional patient samples had incorrect psa results validated and released by the aliniq ams rule to the lis.Customer was informed about the outcomes of the analysis.Once customer detected the issue, rerun the sample where incorrect psa results were initially observed and released.Correct results where then sent out patient.No impact to patient management was reported.The analysis of the search returned no nonconformances or potential nonconformances related to the issue described in the current complaint.Labeling review concludes that the issue is adequately addressed.Based on the available information within the complaint, no malfunctions nor deficiencies were identified in the aliniq ams as the middleware behaved as per the configurations set at this site.

• 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: 18737902
• MDR Text Key: 335738285
• Report Number: 3004032053-2024-00003
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 00380740145125
• UDI-Public: 00380740145125
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/19/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 03R89-24
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1