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

Catalog Number	03R89-21
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for section a1 patient identification: sids (b)(6).Section e1 - email complete entry = (b)(6).
Event or Problem Description
The customer observed errors in the aliniq ams software causing incorrect c3 and c4 complement results to be generated.Customer states there was a typo on the upload code from a3600 automation system to ams and lis.The errors were as follows: ams - the c3 upload code from a3600 was incorrectly set as c4, however fixed immediately.The c3 and c4 complements had correct results on the alinity as follows: sample id (b)(6): c3 = 103.4 and c4 = 18.2.On the ams the correct values appeared for c3, but no value appeared on c4.Lis - on receiving c3 results, they were being replicated also as c4.C3 and c4 had the same value as c3.Once the typo was fixed, services were restarted, results were resent.The customer erased results on the lis, which caused tests to be repeated; however, this time, results were fine.The following is a list of patient id¿s and the request id that potentially were affected.Not all id¿s had bad results in ams, but they did have bad results in lis, due to a misconfiguration: patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).Patient id (b)(6), request id in ams (b)(6).No impact to patient management was reported.
Event or Problem Description
The customer observed errors in the aliniq ams software causing incorrect c3 and c4 complement results to be generated.Customer states there was a typo on the upload code from a3600 automation system to ams and lis.The errors were as follows: ams - the c3 upload code from a3600 was incorrectly set as c4, however fixed immediately.The c3 and c4 complements had correct results on the alinity as follows: sample id (b)(6) = 103.4 and c4 = 18.2 on the ams the correct values appeared for c3, but no value appeared on c4.Lis - on receiving c3 results, they were being replicated also as c4.C3 and c4 had the same value as c3.Once the typo was fixed, services were restarted, results were resent.The customer erased results on the lis, which caused tests to be repeated; however, this time, results were fine.The following is a list of patient id¿s and the request id that potentially were affected.Not all id¿s had bad results in ams, but they did have bad results in lis, due to a misconfiguration: patient id (b)(6), request id in ams 10262981 patient id (b)(6), request id in ams 10266350 patient id (b)(6), request id in ams 11401828 patient id (b)(6), request id in ams 11401841 patient id (b)(6), request id in ams 11416065 patient id (b)(6), request id in ams 11416067 patient id (b)(6), request id in ams 11418998 patient id (b)(6), request id in ams 11435562 patient id (b)(6), request id in ams 21198508 patient id (b)(6), request id in ams 21199094 patient id (b)(6), request id in ams 21199505 patient id (b)(6), request id in ams 21199756 patient id (b)(6), request id in ams 21267093 patient id (b)(6), request id in ams 21267097 patient id (b)(6), request id in ams 21306555 patient id (b)(6), request id in ams 21306601 patient id (b)(6), request id in ams 21326076 patient id (b)(6), request id in ams 21498727 patient id (b)(6), request id in ams 21511196 patient id (b)(6), request id in ams 21591024 patient id an (b)(6), request id in ams 21591050 no impact to patient management was reported.
Additional Manufacturer Narrative
Section h4 - device mfg date: updated from blank to 3/22/2018.Through the investigation it was determined that the inconsistency of test results between the middleware and the instruments was due to a misconfiguration of the c4 assay code that was configured by the engineer using the c3 upload code instead.Since the upload channel for test c4 was not correctly configured (correct channel has to be c4 but it was c3 instead), aliniq ams was not able to import any c4 results coming from the instrument, therefore no c4 tests were resulted in aliniq ams, while c3 results were generated correctly.The issue was resolved through a configuration change within the aliniq ams middleware settings at the customer site: the upload channel code of the c4 test was properly associated in the analyzer section on aliniq ams so that correct values were then released by aliniq ams and sent to the lis.A device history record was reviewed and did not identify any non-conformances or potential non-conformances related to the issue under review.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and adequately addresses the issue under review.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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18020985
• Report Number: 3004032053-2023-00028
• Device Sequence Number: 6650690
• Product Code: JQP
• UDI-Device Identifier: 00380740158255
• UDI-Public: 00380740158255
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 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: 03R89-21
• Device Lot Number: OCN01321-801-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2018
• 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