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

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported an issue involving the reporting of mononuclear (mn) and polymorphonuclear (pmn) body fluid cell counts within the flexlab x workflow.The problem was identified on (b)(6) 2026, when the laboratory noticed that mn and pmn results displayed in the laboratory information system (lis) did not correspond to the values displayed by the analyzer interface.According to the information provided, the results for mononuclear cells were displayed as polymorphonuclear in the lis, and vice versa.According to the information shared by the distributor, the misreporting occurred between (b)(6) 2026.During this period, 15 samples from 8 patients were affected.For one of them, the inverted mn/pmn values contributed to the continuation of unnecessary antibiotic therapy for approximately two additional days.
Additional Manufacturer Narrative
The distributor confirmed that the third party analyzer (advia hema) was performing within specifications and that no malfunction of the instrument was detected.The discrepancy was attributed to a configuration error within flexlab x software data management system (dms), which transmits the test orders and test results between the third party instruments and lis.In dms the request/result transmission codes for the two tests had been incorrectly configured.According to the distributor investigation, the issue originated from a mistake made by their service personnel during the dms configuration, although no detailed explanation of the specific configuration step involved was provided.They also clarified that the inpeco documentation used during the configuration was correct.Therefore, no further actions foreseen.

• 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: 25121569
• Report Number: 3010825766-2026-00002
• Device Sequence Number: 12970140
• Product Code: JQP
• UDI-Device Identifier: 07640172344002
• UDI-Public: (01)07640172344002(11)260313
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 05/08/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown