MAUDE Adverse Event Report: INPECO SA APTIO AUTOMATION; LABORATORY AUTOMATION SYSTEM

Model Number	AP2
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the data received from the field, after the 4 sample tubes were diverted into the bioplex 2200 im, inpeco data management software correctly replied to the analyzer queries and communicated the test orders of each tube.After the first sample tube remained in the sampling position without receiving the complete message from the analyzer, the error messages "f30a sampling complete message not arrived timeout expired" and "f398 analyzer in error " were generated: as consequence of these errors by design the first tube is flagged with error and sent to the input output module priority output rack to be manually managed by the operators and the im is blocked.The operators recovered the error and manually loaded the 4 sample tubes on the analyzer to repeat the tests.The investigation is still ongoing: inpeco has asked for additional data to determine the root cause of the event in collaboration with the analyzer manufacturer.
Event or Problem Description
The event occurred at the bioplex 2200 interface module (im) which connects the third party's analyzer to the inpeco aptio automation track.The third party's analyzer is a "point of space", thus is able to sample the tube without removing it from the automation track.The customer reported that a sample tube at the sampling position of the bioplex 2200 interface module was aspirated 4 times and that the test results obtained from this tube were associated also to the other 3 sample tubes in queue inside the im pit lane.The customer did not report any impact on the involved patients.
Additional Manufacturer Narrative
Initial report submitted on october 6th, 2022.Additional information: no evidence has been found of any issue of the automation system which is behaving according to the communication protocol with the analyzer.Based on inpeco's investigation, aptio automation was not a contributory cause of the incident.The investigation has not highlighted the need of any corrective action on the field.

• Brand Name: APTIO AUTOMATION
• Common Device Name: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• Manufacturer (Section G): INPECO SPA; via givoletto 15; val della torre, 10040 ; IT 10040
• Manufacturer Contact: eva balzarotti ; via torraccia 26; novazzano 6883 ; SZ 6883
• MDR Report Key: 15549736
• Report Number: 3010825766-2022-00003
• Device Sequence Number: 2796717
• Product Code: CEM
• UDI-Device Identifier: 07640172342008
• UDI-Public: (01)07640172342008(11)200515
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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: AP2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown