MAUDE Adverse Event Report: INPECO SA ACCELERATOR A3600; LABORATORY AUTOMATION SYSTEM

Model Number	ACP
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	12/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still ongoing.
Event or Problem Description
The customer reported a sample tube id mismatch occurred at the centrifuge module which connects the automation system track to the third party's centrifuge.The tube a has been released by the centrifuge module with the sample id of another tube present in the centrifuge (tube b).The tube a has been sent to the analyzers to be tested according to the test orders received for tube b.When the real tube b has been then released by the centrifuge module, it has been flagged as duplicate and unloaded into the priority output rack dedicated to sample tubes with error messages at the input output module to be manually managed by the operators.The operator retrieved the tube wrongly identified as b and noticed that it was tube a.He blocked and corrected the results obtained from tube a.
Additional Manufacturer Narrative
The initial report was submitted on january 12th, 2022.Additional information: the log analysis confirmed that the carrier was diverted into the centrifuge module with sample tube "a" and then it was released into the main lane with another sample tube "b" associated, but still tube "a" physically on it.However, the time stamps in the log files are not compatible with the timing needed by the carrier to physically cover the space between the previous node (when the carrier is logically enqueued into the centrifuge module) and the centrifuge module load gate where the carriers are released back into the main lane.It has not been possible to reproduce the scenario in house nor to determine the root cause of the event.From the field the customer did not report any other occurrences.No similar complaints have been received from other sites.The investigation outcome is that the problem in not reproducible.Further evaluations will be done in case of new evidence/information from the field.

• Brand Name: ACCELERATOR A3600
• Common Device Name: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano 6833 ; SZ 6833
• 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: 13236130
• Report Number: 3010825766-2022-00001
• Device Sequence Number: 14634649
• Product Code: CEM
• UDI-Device Identifier: 07640172341001
• UDI-Public: (01)07640172341001(11)181023
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 04/07/2022

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: ACP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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