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

Catalog Number 03R89-20

Device Problem Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed incorrect previous (historical) results for a patient displayed on the aliniq ams when using the ams software version (b)(4).The customer stated that the wrong patient data appeared in the previous results field for one patient displayed on the aliniq ams screen.Also, the time that appeared with the previous results report was 1:30 am and the laboratory is closed at that time.The historical results were not reported out of the lab.The current results displayed in the aliniq ams database were the correct results.It is unclear at this time how the incorrect historical results were displayed in aliniq ams and whether the results were retrieved from the customer¿s lis or retrieved from the ams database.There was no impact to patient management reported.

Manufacturer Narrative

Investigation performed by the technical group on aliniq ams database were conducted to verify the results archived and released.It was confirmed that previous results, transmitted between laboratories in the multi-site were properly managed and released by aliniq ams as per the defined configuration: previous results were sent from urgency (urg_lab) to core-lab (cnlab) and core-lab (cnlab) considered previous sample results for its evaluations, even if those results were not produced in the core-lab (cnlab).Trending was reviewed and determined no trends were identified.The device history record was reviewed and did not identify any non-conformances or deviations related to the issue described in the complaint.Labeling was reviewed and adequately addresses the issue under review.The customer considered the previous results displayed by aliniq ams in cnlab as an incorrect behavior of the application due to a misunderstanding of the sample workflow management through the multi-laboratory.Based on the available information, neither deficiencies nor malfunctions were identified in aliniq ams middleware: samples and previous results were properly managed by aliniq ams according to the multi-site configuration.

Manufacturer Narrative

Updated section d10: concomitant product: aliniq ams base softwar, 03r89-22, oce00915_005.

• Brand Name: ALINIQ AMS
• Type of Device: 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12795603
• MDR Text Key: 281664196
• Report Number: 3004032053-2021-00002
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 03R89-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 10/20/2021; 12/13/2021
• Supplement Dates FDA Received: 11/11/2021; 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINIQ AMS BASE SOFTWAR, 03R89-22, OCE00915_005; ALINIQ AMS BASE SOFTWAR, 03R89-22, OCE00915_005