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

Catalog Number	03R89-48
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for section a patient information, 1.Patient identifier = sid= (b)(6).
Event or Problem Description
The customer observed incorrect assay results on ams aniq software which connected to architect c16000 processing module.The abbott field service engineer (fse) performed track upgrade.The architect c16000 processing module connected directly to ams software during track upgrade.The fse performed the assay mapping on ams software due to track upgrade.The fse incorrectly mapped the assay iron instead of the assay ferritin.The physician found out when received the results for iron instead of the ferritin.The ferritin results delayed due to incorrect mapping issue on ams software by the abbott fse.The iron results reported out of the laboratory instead of ferritin.The fse configurated correct assay in ams software which resolved the issue.No discrepant patient results provided by the customer.No further impact to patient management.
Event or Problem Description
The customer observed incorrect assay results on ams aniq software which connected to architect c16000 processing module.The abbott field service engineer (fse) performed track upgrade.The architect c16000 processing module connected directly to ams software during track upgrade.The fse performed the assay mapping on ams software due to track upgrade.The fse incorrectly mapped the assay iron instead of the assay ferritin.The physician found out when received the results for iron instead of the ferritin.The ferritin results delayed due to incorrect mapping issue on ams software by the abbott fse.The iron results reported out of the laboratory instead of ferritin.The fse configurated correct assay in ams software which resolved the issue.No discrepant patient results provided by the customer.No further impact to patient management.
Additional Manufacturer Narrative
The investigation performed by the aliniq ams technical group indicated that the issue was due to an incorrect configuration of the test-channel association performed by the abbott informatics technical specialist during the instrument configuration performed due to a track (a3660, provided by inpeco) upgrade.The issue was resolved through a configuration change within the aliniq ams middleware settings at the customer site performed by the abbott informatics technical specialist: channel codes of the ferritin test was properly associated in the analyzer section on the middleware.A review of the labeling addresses the customer¿s issue: the ams configurator user manual 3.01 provides adequate information how to configure the test-channel codes used by the windows services managing communications with the analyzer.The upload channel is the assay number identifying the result coming from the instrument (based on what configured directly into the instrument for that assay e.G.: measurement unit).The download channel is the assay code sent from the middleware to the analyzer to perform the test.A review of tracking and trending of the aliniq found additional four complaints related to the similar complaint issue tickets (b)(4).All these issues were due to incorrect configuration of the test-channel association in the analyzer section of aliniq ams,therefore, no trends were identified.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Based on the investigation the aliniq ams is performing as intended, no systemic issue or deficiency of 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: 18013184
• Report Number: 3004032053-2023-00027
• Device Sequence Number: 7469590
• Product Code: JQP
• UDI-Device Identifier: 00380740189914
• UDI-Public: 00380740189914
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 11/28/2023

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: 03R89-48
• 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: 10/09/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2020
• 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