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

Catalog Number	03R89-47
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed negative result values for hemoglobin, hematocrit, and mcv in the aliniq ams software, which were released into the laboratory information system.The customer uses the alinity hq analyzer for patient blood and stem cells.In the aliniq ams software, there was a rule set up to distinguish these sample types (x and *).After the alinity hq analyzer software upgrade, the rule no longer functioned correctly.Both flags (x and *) appeared together, causing the result to go from 0.00 to -1.The results example provided were as below: sid 7925347373 hematocrit from alinity hq=1.41x* /transmitted to lis by ams=-1 sid 8001697273 hematocrit from alinity hq=0.00x* / transmitted to lis by ams=-1; hemoglobin from alinity hq=0.024x* / transmitted to lis by ams=-1; mcv from alinity hq=0.00x* / transmitted to lis by ams=-1 the abbott fsr reconfigured ams rule to cover both flagging after new software upgrade.There was no reported impact to patient management.
Additional Manufacturer Narrative
Complete information for section a patient information, 1.(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 observed negative result values for hemoglobin, hematocrit, and mcv in the aliniq ams software, which were released into the laboratory information system.The customer uses the alinity hq analyzer for patient blood and stem cells.In the aliniq ams software, there was a rule set up to distinguish these sample types (x and *).After the alinity hq analyzer software upgrade, the rule no longer functioned correctly.Both flags (x and *) appeared together, causing the result to go from 0.00 to -1.The results example provided were as below: sid (b)(6) hematocrit from alinity hq=1.41x* /transmitted to lis by ams=-1.Sid (b)(6) hematocrit from alinity hq=0.00x* / transmitted to lis by ams=-1; hemoglobin from alinity hq=0.024x* / transmitted to lis by ams=-1; mcv from alinity hq=0.00x* / transmitted to lis by ams=-1.The abbott fsr reconfigured ams rule to cover both flagging after new software upgrade.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation on the aliniq ams software included a review of data and information provided by the customer, search for similar complaints, ticket trending review, and labeling review.The aliniq ams technical group investigated the "strtofloat" function in the ams rule is designed to return a default value of -1, when it fails to convert a number from string to a float format.This new format caused the "strtofloat" function to fail, hence returning -1.The ams rule functioned correctly based on its original design.The observed issue arose due to a change in the input format of the alinity h software.No deficiency was identified.The customer requested a revised rule capable of stripping multiple characters simultaneously.Abbott technical experts will review and validate the updated rule to ensure it performs correctly.A review of labeling and historical data was done, and both were adequate, with no increase in complaint activity.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency of aliniq ams middleware, version 2.11, 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: 21920866
• Report Number: 3004032053-2025-00013
• Device Sequence Number: 8720229
• Product Code: JQP
• UDI-Device Identifier: 00380740189907
• UDI-Public: (01)00380740189907(10)2.11
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/16/2025

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: 03R89-47
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 07/16/2025
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown