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

Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
The customer reported an occurrence of an already known issue of the aliquoter module x (malx).The 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 malx and do not empty the printer tubes buffer removing all the secondary sample tubes.In this case the operator was recovering the error m34cc "tube hopper move to up position failure" which did not actually require to open the printer head.In this laboratory the secondary tubes are sorted into an input output module (iox) output rack.For the secondary sample tube with the wrong information printed on the label, if the rack is unlocked from the lane and the tube is re-loaded on the automation system or is tested off track, the mismatch between the label information and actual sample cannot be detected and the event may lead to incorrect results.The operator may become aware of the mismatch when the impacted secondary tube is unloaded in a position of the iox rack that doesn't match the one displayed on the user graphic interface.For the secondary sample tube without label the traceability is lost when the sample tube is unloaded from the carrier.The event may cause delayed test results in case of tests to be executed off track.According to the information provided by the distributor the customer has detected discordant result in several secondary samples.No real clinical impacts on the involved patients have been reported.

• Brand Name: FLEXLAB X
• 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: 23523280
• Report Number: 3010825766-2025-00007
• Device Sequence Number: 15888361
• Product Code: JQP
• UDI-Device Identifier: 07640172344002
• UDI-Public: (01)07640172344002(11)250624
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: 505
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (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