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

Catalog Number	03R89-62
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1: patient identifier: sids: (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported an incorrect assay was performed while using the aliniq ams software.In the customer¿s lis (laboratory information system), test code 162 was for total bilirubin in body fluid (not blood).In the aliniq ams software, test code 162 was misconfigured as direct bilirubin (body fluid).When the aliniq ams software received an order for body fluid (samples with sid ending in.34), it ordered direct bilirubin instead of total bilirubin.The direct bilirubin results were then sent to the customer¿s lis and were being reported as total bilirubin.The customer provided the following affected patient id¿s: (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6).There was no impact to patient management reported.
Event or Problem Description
The customer reported an incorrect assay was performed while using the aliniq ams software.In the customer¿s lis (laboratory information system), test code 162 was for total bilirubin in body fluid (not blood).In the aliniq ams software, test code 162 was misconfigured as direct bilirubin (body fluid).When the aliniq ams software received an order for body fluid (samples with sid ending in.34), it ordered direct bilirubin instead of total bilirubin.The direct bilirubin results were then sent to the customer¿s lis and were being reported as total bilirubin.The customer provided the following affected patient id¿s: sid (b)(6).Sid (b)(6).Sid (b)(6).Sid (b)(6).Sid (b)(6).Sid (b)(6).Sid (b)(6).There was no impact to patient management reported.
Additional Manufacturer Narrative
Section d4 - primary udi number: this was corrected from (b)(4).The investigation verified the information provided by the customer and confirmed the test code misconfiguration as the root cause of the complaint issue.The technical expert corrected the lis test code association for "162" to "biltbio" (total bilirubin) on ams and the issue was resolved.A complaint trending report was reviewed and did not identify any similar complaints.The current ticket is the sole complaint for the reported issue.The device history record 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 middleware is performing as intended, no systemic issue or deficiency of the aliniq ams middleware 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: 18682892
• Report Number: 3004032053-2024-00002
• Device Sequence Number: 20694131
• Product Code: JQP
• UDI-Device Identifier: 00380740200169
• UDI-Public: (01)00380740200169(10)3.01
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03R89-62
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 02/11/2024
• Supplement Report FDA Received Date: 04/18/2024
• 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: Unknown