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

Model Number	03R89-48
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
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.There was no additional patient information provided by the customer.
Event or Problem Description
The customer reported that for approximately 85 patient samples managed jointly by abbott and roche, when all the samples have been tested by the abbott analyzer and produced results, the ams added a new rule to set the default value of 1 for the roche classified assays (s_roche).This default is not shielded and will also be transmitted to the lis, meaning all results that are classified s_roche will be sent to the lis as 1.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation indicated that the root cause of the issue was an incorrect configuration of the of the product performed by the aliniq ams engineer.The issue happened because the results for the test ¿s_roche¿ were not prevented being sent to the lis through the aliniq ams configuration.As a resolution, the configuration of the flag ¿send to lis after validation¿ on aliniq ams was modified to avoid the transmission of the test results to the lis after validation.Additionally, a configuration change was also implemented on the lis side, to discard ¿s_roche¿ results when received from the aliniq ams.As a consequence, ¿s_roche¿ results, if still received from aliniq ams, wouldn¿t be displayed any more on the lis interface.No adverse trend was identified for the customer's issue.A review of the labeling addresses the customer¿s issue.Based on all available information and abbott diagnostics' complaint investigation, no product deficiency 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
• MDR Report Key: 12180358
• Report Number: 3004032053-2021-00001
• Device Sequence Number: 11469490
• Product Code: JQP
• UDI-Device Identifier: 00380740189914
• UDI-Public: 00380740189914
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 08/03/2021

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
• Operator of Device: Health Professional
• Device Model Number: 03R89-48
• Device Catalogue Number: 03R89-48
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1