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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  malfunction  

Event Description

A us customer reported that an erratic result was obtained from an aliquoted tube generated on the flexlab automation system.The mother tube was loaded on the automation system: the volume was evaluated sufficient, so the tube was diverted to the aliquoter module (alq).A single daughter tube was generated without any error message.The daughter tube was recapped and unloaded to be tested for the antinuclear antibody (ana) assay off-track.A negative result was obtained.The result was challenged by the doctor who ordered a rerun on the mother tube and on another primary tube of the same patient.Both the results were positive.The customer noted the color of the serum in the daughter tube seemed clear and suspected it may have been diluted with the water of the alq tube system without any warning.Based on the information received from the customer, no harm came to the patient and no delay in treatment occurred.The customer also requested a check of the sample tubes managed by the aliquoter module before and after the impacted mother tube and no problems with results were identified for those tubes.

Manufacturer Narrative

The distributor directly investigated the event checking the aliquoter module when the problem was reported.No problems were identified and no actions or repairs were required.Inpeco is continuing the investigation to determine if the aliquoter module contributed to the event diluting the daughter tube.

Manufacturer Narrative

The initial report was submitted on march 6th, 2024.Additional information: inpeco completed the investigation checking the aliquoter module configurations and confirmed that the set parameters are correct.The distributor already checked the aliquoter module on site: no problems were identified and no actions or repairs were required.The investigation has not identified any issue in the aliquoter module which is working as expected.There is no reason to suspect that the aliquoter module has diluted the secondary tube.No additional actions are foreseen.

• Brand Name: FLEXLAB
• Type of Device: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• Manufacturer (Section G): INPECO SPA; via givoletto; val della torre, 10040 ; IT 10040
• Manufacturer Contact: eva balzarotti ; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 18844203
• MDR Text Key: 337154622
• Report Number: 3010825766-2024-00001
• Device Sequence Number: 1
• Product Code: CEM
• UDI-Device Identifier: 07640172340004
• UDI-Public: (01)07640172340004(11)200518
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1