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

Medical Device Problem Codes	Installation-Related Problem (2965); Mechanical Jam (2983); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still ongoing.
Event or Problem Description
A customer outside us reported a sample tube id mismatch occurred at the centrifuge module which connects the automation system track to the third party's centrifuge.The involved sample tubes were a tube which should have been diverted into the centrifuge module but remained on the main track (tube a) and a sample tube loaded into the centrifuge (tube b).The carrier which was physically transporting tube a was erroneously associated to tube b.Tube a was flagged with error sc06d "tube lost in pick and place module".The real tube a was sent to the analyzers to be tested according to the test orders received for tube b.The test ordered for tube b should have been executed on a centrifuged sample (serum or plasma) while tube a was still a whole blood sample.The obtained results were out of normal range.The sample tube was sorted in a rack of iom#2.When the operator performed the visual check on the sample before re-run, he became aware of the sid mismatch issue.He blocked the results obtained from tube a.When the real tube b was then released by the centrifuge module, it was flagged as duplicate (sc00e) and unloaded into the priority output rack dedicated to sample tubes with error messages at the input output module (iom#1) to be manually managed by the operators.Both tube a and tube b were re-centrifuged in a standalone centrifuge and the samples were manually placed into the analyzer for the assays run.According to the provided information there were no impacts on the involved patients: no medication nor treatment was delayed or cancelled.
Additional Manufacturer Narrative
Additional information: the association of the sample tube to the wrong carrier was caused by a carrier jam at the centrifuge module exit which led the carriers already released to be pushed back on the antenna at the load gate.The distributor field service engineer (fse) verified the antenna and stop gate functioning and alignment.He discovered that the track profile was not correctly placed by fse preventing the smooth passage of the carriers.He reseated the exit lane assembly and replaced the buffer lane stop gate and diverter fixing the carrier routing issues.The service manual already describes how to correctly install the exit lane assembly.No additional actions are foreseen.

• Brand Name: ACCELERATOR A3600
• 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: 18090543
• Report Number: 3010825766-2023-00013
• Device Sequence Number: 12429779
• Product Code: CEM
• UDI-Device Identifier: 07640172341001
• UDI-Public: (01)07640172341001(11)170526
• 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: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 05/29/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown