MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY CI-SERIES SYSTEM CONTROL MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03R70-01
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A results mix up occurred involving two sample ids.The customer reported an issue involving incorrect results appearing in their laboratory information system (lis) (seacoast laboratory data systems).After testing on (b)(6) 2026, a physician questioned the lipid panel results on (b)(6) 2026.The customer re-ran the patient sample, and the alinity results matched the original analyzer results, but did not match the values shown in the laboratory information system (lis).To investigate further, the customer also re-ran the comprehensive metabolic panel (cmpn), and again the lis results did not match.Sample id (b)(6) received test results that did not belong to this sample.The results that were posted to sample id (b)(6) were the correct results for sample id (b)(6).As a result, sample id (b)(6) did not receive its own results, and sample id (b)(6) was reported with incorrect results.The following data was provided: tested on (b)(6) 2026, (b)(6).Trig = 134 mg/dl.Hdl = 37 mg/dl.Chol2 = 89 mg/dl.Glucose = 145 mg/dl.Co2 = 30 mmol/l.Tbili2 = 0.73 mg/dl.Crea2 = 0.91 mg/dl.K-c = 4.04 mmol/l.Na-c = 142 mmol/l.Cl-c = 104 mmol/l.Albumin = 4.41 g/dl.Calcium = 9.2 mg/dl.Tpro = 6.43 g/dl.Alkp = 72 u/l.Urea = 21 mg/dl.Ast2 = 15 u/l.Alt2 =13 u/l.Tested on (b)(6) 2026, sid (b)(6).Trig = 60 mg/dl.Hdl = 45 mg/dl.Chol2 = 175 mg/dl.Glucose = 102 mg/dl.Co2 = 25 mmol/l.Tbili2 = 0.20 mg/dl.Crea2 = 0.60 mg/dl.Na-c = 139 mmol/l.Cl-c = 106 mmol/l.K-c = 4.39 mmol/l.Albumin = 4.46 g/dl.Calcium = 9.1 mg/dl.Tpro = 6.56 g/dl.Urea = 14 mg/dl.Ast2 = 16 u/l.Alt2 = 12 u/l.Tested on (b)(6) 2026: triglyceride = 60 mg/dl.Hdl = 46 mg/dl.Chol2 = 172 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint describes an issue in which the user reported that the lipid panel and comprehensive metabolic panel (cmp) results did not match the results recorded in the lis.The customer¿s lis vendor reviewed the data and found a missing end of transmission (eot) character that should have been between each complete record.A review of tracking and trending did not identify any trends for the alinity ci-series system control module, serial number (b)(6), and the alinity ci software v3.6.0, associated with the issue described in this complaint.A review of the manufacturing documentation did not identify any nonconformances related to the complaint issue.After further investigation, the required system logs were not retrieved on the dates the issue occurred, therefore there was not sufficient information to evaluate the issue further.Review of the alinity ci-series operations manual provides adequate instructions and overview on how the host setup screen displays the interface, transmission, and results release settings, and how to configure host settings.Based on the investigation, no systemic issue or product deficiency of the alinity ci-series system control module for serial (b)(6) or alinity system software v3.6.0 was identified.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
A results mix up occurred involving two sample ids.The customer reported an issue involving incorrect results appearing in their laboratory information system (lis) (b)(4).After testing on (b)(6) 2026, a physician questioned the lipid panel results on (b)(6) 2026.The customer re-ran the patient sample, and the alinity results matched the original analyzer results, but did not match the values shown in the laboratory information system (lis).To investigate further, the customer also re-ran the comprehensive metabolic panel (cmpn), and again the lis results did not match.Sample id (b)(6) received test results that did not belong to this sample.The results that were posted to sample id (b)(6) were the correct results for sample id(b)(6).As a result, sample id (b)(6) did not receive its own results, and sample id (b)(6) was reported with incorrect results.The following data was provided: tested on (b)(6) 2026, (b)(6) trig = 134 mg/dl hdl = 37 mg/dl chol2 = 89 mg/dl glucose = 145 mg/dl co2 = 30 mmol/l tbili2 = 0.73 mg/dl crea2 = 0.91 mg/dl k-c = 4.04 mmol/l na-c = 142 mmol/l cl-c = 104 mmol/l albumin = 4.41 g/dl calcium = 9.2 mg/dl tpro = 6.43 g/dl alkp = 72 u/l urea = 21 mg/dl ast2 = 15 u/l alt2 =13 u/l tested on 1(b)(6) 2026, sid (b)(6) trig = 60 mg/dl hdl = 45 mg/dl chol2 = 175 mg/dl glucose = 102 mg/dl co2 = 25 mmol/l tbili2 = 0.20 mg/dl crea2 = 0.60 mg/dl na-c = 139 mmol/l cl-c = 106 mmol/l k-c = 4.39 mmol/l albumin = 4.46 g/dl calcium = 9.1 mg/dl tpro = 6.56 g/dl urea = 14 mg/dl ast2 = 16 u/l alt2 = 12 u/l tested on (b)(6) 2026: triglyceride = 60 mg/dl hdl = 46 mg/dl chol2 = 172 mg/dl there was no impact to patient management reported.

• Brand Name: ALINITY CI-SERIES SYSTEM CONTROL MODULE
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 24546061
• Report Number: 3016438761-2026-00122
• Device Sequence Number: 20265077
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: 03R70-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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