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

Model Number	03R89-48
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the aliniq ams base software version 2.12 had demographic data not matching between the lifecare now lis and ams.There was no impact as customer reprocessed patient with a new sid number.The following data was provided: in lis lifecare now: lid no: (b)(4).Patient no: 195207134916, customer: (b)(4).In ams: id number (b)(4), personal id: (b)(6).Customer: (b)(4), there was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported that the aliniq ams base software version 2.12 had demographic data not matching between the lifecare now lis and ams.There was no impact as customer reprocessed patient with a new sid number.The following data was provided: in lis lifecare now: lid no: (b)(4); patient no: (b)(6) ; customer: (b)(6) ; in ams: id number (b)(4); personal id: (b)(6) customer: (b)(6) there was no impact to patient management reported.
Additional Manufacturer Narrative
The abbott specialist determined that, on 4th may of 2023 at 11:22 the penguin was managing correctly the orders coming from the lis but at 11:22:22 a saturation of dedicated memory space occurred causing an out of memory issue.Due to this error the system was unable to extract data related to patient 2 (id (b)(6) ) to which sample (b)(6) belonged and the sample was incorrectly matched with the last patient 1 (id (b)(6) ) managed by the system some seconds earlier.Consequently, even the results coming from the analyzer were associated to patient 1.Only the first sample of patient 2 was affected by the mismatch.The incorrect sample assignment to a patient was caused by an out of memory issue which did not permit the correct association of a sample to the corresponding patient.This is the first occurrence of this issue, and it has never been experienced before at other sites.Deep analysis performed by abbott experts did not determine the cause of the saturation of the dedicated memory space within the import service of the penguin.The out of memory error and the sample/patient mismatch appeared likely to have been due to an extemporaneous unexpected and inexplicable situation in the memory management by the operating system.The available data did not permit to confirm the exact reasons or to raise some hypotheses about the causes which led to the aliniq ams gateway out of memory occurrence.No further investigations could be performed based on the available information.The import service re-establishment was achieved by restarting the penguin for immediate amendment of the behavior.No further actions were performed in the middleware.No reoccurrences were reported by the customer after this event.A review of tracking and trending of the aliniq found no additional complaints related to the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation no systemic issue or deficiency with 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16914304
• Report Number: 3004032053-2023-00016
• Device Sequence Number: 20422008
• Product Code: JQP
• UDI-Device Identifier: 00380740189914
• UDI-Public: 00380740189914
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 07/05/2023

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 Model Number: 03R89-48
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/05/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown