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

Medical Device Problem Codes	Output Problem (3005); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported another occurrence of the event described in mdr 3010825766-2025-00003 in the same laboratory.The aliquoter module (alx, #3) caused the mismatch of more than 200 tubes between daughter and mother tubes.The impacted sample tubes had to be manually retrieved by the operators.The mismatch probably started after the error "m34e0 - tube labeled orientation verification activated error" at around 5:11am in the night of the (b)(6) 2025.According to the laboratory workflow, the mother tubes are tested before being sent to the aliquoter module.The aliquot sample tubes can be sorted at the input output module (iox) to perform pcr tests outside the automation system or sent to the tested on the cobas 8000 instrument.In the first case, the operator may become aware of the mismatch when he finds in the sorting rack either a sample tube with a test name printed on the label different from the test name written on the iox display bar or a sample tube with an unexpected sid.If the mismatch is not noticed, the event may lead to incorrect results.The customer did not communicate any real clinical impact on the involved patients.In the second case, due to the analyzer's pick-and-place mechanism, these sample tubes are scanned by a barcode reader before being unloaded from the track.The automation system flagged with the error 5d22 - sample id mismatch the involved tubes and sent them to the error lane of the iox to be manually managed by the operators.
Additional Manufacturer Narrative
The mismatch starts after errors which require to open the aliquoter module printer head if the operators leave sample tubes inside the printer.The investigation is ongoing to determine the specific scenarios which may require the opening of the printer head triggering the issue and to identify how to fix it.
Additional Manufacturer Narrative
The investigation has confirmed that the aliquoter module x (malx) may generate secondary sample tubes without labels or with a label reporting information inconsistent with the actual sample dispensed into the tube.The event occurs if the operators open the printer head of the aliquoter module x (malx) and do not empty the printer tubes buffer removing all the secondary sample tubes.The issue may impact the involved patients only if the secondary sample tubes affected by the issue are routed to an output module and they are unloaded from the automation system.The issue has been fixed in malx increment 1.4.Inpeco has submitted a mandatory corrective action related to this issue (reference code: 3010825766 - 102725 - 002 - c).

• Brand Name: FLEXLAB
• 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, ; IT
• Manufacturer Contact: eva balzarotti ; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 22961997
• Report Number: 3010825766-2025-00006
• Device Sequence Number: 9520018
• Product Code: JQP
• UDI-Device Identifier: 07640172340004
• UDI-Public: (01)07640172340004(11)250211
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown