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

Catalog Number	03R89-63
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 patient identifier complete information: (b)(6).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 observed a potassium result generated on the alinity c processing module incorrectly issued the result to a female patient with a date of birth of (b)(6) with the same sample id.(b)(6)2024 sid (b)(6) was used when validating total automation.Original potassium result ((b)(6)) = 7.643 mmol/l (high flag).The same sample was run on ((b)(6)) on (b)(6)2024 with result = >10.000 mmol/l (>, pshh flags).(b)(6)2024 sid (b)(6), the ams sent the previous potassium result of 7.6 mmol/l from alinity to the lis that was automatically validated and the actual result for the patient with sid (b)(6) = 4.3 mmol/l.The results were sent to lis on (b)(6)2024 as a test sample (unknown sample).The actual sample creation date with the same sample id is (b)(6)2024.The results sent for the test sample were stored by the lis and were visible when the sample was created.The customer reported the cause of the issue was due to the lis buffering; however, further information from the customer was they are uncertain whether the issue is the ams or the non-abbott lis.The patient was given resonium 15 grams dissolved in water as a one time dose and furesis 20 mg intravenously, and the patient had been on spironolactone medication, which was discontinued because spironolactone can reduce potassium secretion.The patient had an ecg, that was ok with no abnormal findings.The error was noticed and the department was informed that the 7.6 mmol/l result was erroneous and the correct result was 4.3 mmol/l.Approximately 1-2 hours after the patient was given the resonium, the resonium was discontinued, and the spironolactone was resumed.Later that day, extra lab tests were performed, and the potassium result for the same patient with sid (b)(6) was 4.4 mmol/l.The customer reported there was no harm as a result and the patient did not have any adverse effects at any point.No further impact to patient management was reported.
Event or Problem Description
The customer observed a potassium result generated on the alinity c processing module incorrectly issued the result to a female patient with a date of birth of (b)(6) 1930 with the same sample id.On (b)(6) 2024, sid (b)(6) was used when validating total automation.Original potassium result (b)(6) = 7.643 mmol/l (high flag).The same sample was run on (b)(6) on (b)(6) 2024 with result = >10.000 mmol/l (>, pshh flags).On (b)(6) 2024, sid (b)(6), the ams sent the previous potassium result of 7.6 mmol/l from alinity to the lis that was automatically validated and the actual result for the patient with sid (b)(6) = 4.3 mmol/l.The results were sent to lis on (b)(6) 2024 as a test sample (unknown sample).The actual sample creation date with the same sample id is (b)(6) 2024.The results sent for the test sample were stored by the lis and were visible when the sample was created.The customer reported the cause of the issue was due to the lis buffering; however, further information from the customer was they are uncertain whether the issue is the ams or the non-abbott lis.The patient was given resonium 15 grams dissolved in water as a one time dose and furesis 20 mg intravenously, and the patient had been on spironolactone medication, which was discontinued because spironolactone can reduce potassium secretion.The patient had an ecg, that was ok with no abnormal findings.The error was noticed and the department was informed that the 7.6 mmol/l result was erroneous and the correct result was 4.3 mmol/l.Approximately 1-2 hours after the patient was given the resonium, the resonium was discontinued, and the spironolactone was resumed.Later that day, extra lab tests were performed, and the potassium result for the same patient with sid (b)(6) was 4.4 mmol/l.The customer reported there was no harm as a result and the patient did not have any adverse effects at any point.No further impact to patient management was reported.
Additional Manufacturer Narrative
The technical investigation determined that the issue arose because old results for testing/unknown samples during the testing phase were not deleted by the customer's lis.When a new order with the same sample id is created, these old results are linked to the new sample, causing the lis to cancel repeated tests and preventing the aliniq ams from forwarding the order to the instrument.Data and information provided by the customer were reviewed.Ticket tracking and trending identified no additional complaints similar to the issue described in the current complaint.A device history record review was reviewed and did not identify any non-conformances or potential non-conformances related to the issue described in the current complaint.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, the aliniq ams is performing as intended, therefore, there is no systemic issue or deficiency of the aliniq ams was identified.The middleware functioned as expected at the customer site.All available patient information was included.Additional patient details are not available.

• 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: 21219766
• Report Number: 3004032053-2025-00001
• Device Sequence Number: 3467268
• Product Code: JQP
• UDI-Device Identifier: 00380740202736
• UDI-Public: (01)00380740202736(10)3.02
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 02/06/2025

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: 03R89-63
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female