MAUDE Adverse Event Report: INPECO SA ACCELERATOR A3600; LABORATORY AUTOMATION SYSTEM

Device Problems Use of Device Problem (1670); Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

Service is trained personnel for the installation, use and maintenance of the automation system.The service manual already recommends wearing appropriate personal protective equipment (ppe) when working in a lab environment, which may include anti-cutting gloves handling metal panel.The fse should have cleaned the sample residues on the track panel and should have removed the panel before working on the pneumatic tubing in order to work in a safe way.The current design of the lateral panel is considered adequate: the panels are checked for sharp edges by the supplier.The service manual is complete.An additional follow up is foreseen when the fse will repeat the blood analysis.

Event Description

During the decommissioning of a cobas 8000 interface module, a field service engineer (fse) got injured removing some of the pneumatic tubing.Specifically he scratched his hand on the track panel which had evidence of specimen splashing.The fse was wearing the laboratory coat and latex gloves, but the gloves got pierced and the exposed skin was superficially scratched drawing blood.The fse washed his hands and used alcohol swabs on the infected area.As a precaution, the hospital drew blood to test for a baseline panel including hepatitis and hiv which all came back negative.Additionally, the fse received a tetanus shot and was prescribed post exposure prophylaxis to take for twenty-eight days following exposure and return to family doctor for repeat blood work to ensure the results are still negative.

Manufacturer Narrative

The initial report was sent on september 1st, 2023.According to the additional information received on september 14th, 2023 the fse repeated the blood analysis for the infectious disease panel test and it all came back negative.No additional actions are foreseen.

• Brand Name: ACCELERATOR A3600
• 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 15; val della torre, 10040 ; IT 10040
• Manufacturer Contact: eva balzarotti ; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 17669399
• MDR Text Key: 322477316
• Report Number: 3010825766-2023-00008
• Device Sequence Number: 1
• Product Code: CEM
• 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: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2023
• 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
• Patient Outcome(s): Other