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	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed incorrect tests linked to a sample id number in the aliniq ams base software for a patient sample.The customer reported that cbc test orders (bar code (b)(4)), sent by the lis, were mismatched in the ams with clinical chemistry tests that belonged to another sample (bar code (b)(4)).The results were not released.No impact to patient management was reported.
Additional Manufacturer Narrative
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 incorrect tests linked to a sample id number in the aliniq ams base software for a patient sample.The customer reported that cbc test orders (bar code 0014494703), sent by the lis, were mismatched in the ams with clinical chemistry tests that belonged to another sample (bar code 0014494704).The results were not released.No impact to patient management was reported.
Additional Manufacturer Narrative
H4 - device mfg date updated from blank to 4/27/2022.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed incorrect tests linked to a sample id number in the aliniq ams base software for a patient sample.The customer reported that cbc test orders (bar code 0014494703), sent by the lis, were mismatched in the ams with clinical chemistry tests that belonged to another sample (bar code 0014494704).The results were not released.No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information section d10 concomitant product updated from blank to ams lis connection, 03r89-27and h4 - device mfg date updated from blank to 4/27/2022.The technical complaint investigation confirmed that the problem was caused by a misinterpretation of the protocol by the lis system that did not implement the requirements defined in aliniq astm/hl7 host connection specifications (astm low level protocol) of the message sequence received.Two errors in the message order handling received from lis were observed: 1) the reception of p and o records while aliniq ams turned to idle state.2) the missing transmission of from lis after the previous transaction was interrupted.The abnormal, incorrect sequence of events received from lis reported above, caused the aliniq ams driver to not clean the previous test list and to append it to the new sample received: as aliniq ams sent character for communication interruption, the sender system should have sent character.The communication, instead, continued transmitting new patient and order records, which led the aliniq ams driver to not release the previous test list and assign it to the new sample received: sample 0014494703 was overwritten with tests from sample 0014502112.No incorrect or delayed patient results were released.The lis is expected to send an message before initiating a new astm session according with the astm protocol and driver specifications.Outcome of the investigation is to have the lis vendor aware that they are requested to respect the specifications modifying their interface to correctly behave when receiving message from ams.Transmission should be interrupted and restarted from the affected records transmission.Customer confirmed the lis was informed.A complaint trending report was reviewed and identified no additional complaints similar to the issue described in the current complaint.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 is performing as intended, therefore no systemic issue or deficiency of the aliniq ams, software and/or drivers 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: 17905031
• Report Number: 3004032053-2023-00025
• Device Sequence Number: 7560670
• Product Code: JQP
• UDI-Device Identifier: 00380740200169
• UDI-Public: 00380740200169
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 03/05/2024

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: 09/29/2023
• Supplement Date Received by Manufacturer: 01/04/2024; 02/28/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 01/30/2024; 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMS LIS CONNECTION, 03R89-27,
• Patient Sex: Unknown