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

Device Problem Use of Device Problem (1670)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

The labeling has been reviewed and considered appropriate.In the operations manual it has already recommended to use caution when accessing parts of the module normally protected by covers since sharp surfaces can be reached.In the cobas 8000 interface module section there is a warning to advise the operators about the cutting hazard due to the sharp surface of the robot gripper.The health conditions of the fse will be kept monitored.

Event Description

A field service engineer got a cut on his hand while he was working on the cobas 8000 interface module (im) to fix a malfunction of the im robot gripper which moves uncapped tubes.When the injury occurred the fse was wearing ppe, but the gripper fingers pierced the gloves.The cut was disinfected and bandaged.A blood test was immediately performed: all test results were negative.The blood tests will be repeated after 3 months and 6 months.

Manufacturer Narrative

Initial mdr 3010825766-2020-00003 was submitted on march 5th, 2020.New information: the fse repeated the blood tests after 3 and 6 months.The results were negative for infections.The event has been considered as a human error and no design changes are foreseen.

• Brand Name: FLEXLAB
• Type of Device: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 9792268
• MDR Text Key: 183322736
• Report Number: 3010825766-2020-00003
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• PMA/PMN Number: K121012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1