MAUDE Adverse Event Report: INPECO SA ACCELERATOR A 3600; LABORATORY AUTOMATION SYSTEM

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Joint Dislocation (2374)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The laboratory employee was doing the recovery of error 2185 "tip blocked in chamber" when he/her injured him/herself.According to the information provided by the client, the employee is under medical care, and he/she is absent from work 17 days as of (b)(6).It is still unknown if other medical treatments have been performed.The first instruction of the troubleshooting procedure is "contact the service assistant to perform the following steps", but he/her did not do it.Moreover, he/her removed the long upper side panel, that was not to be removed according to the procedure itself.Therefore, the design of the aliquoter module's panel and the procedure to handle it are considered adequate.No actions are foreseen to be taken by inpeco.
Event or Problem Description
The client reported that a laboratory operator was injured during troubleshooting of a "tip chamber jam" on the aliquoter module.The employee removed the long upper side panel and hit him/herself on the jaw causing a dislocation.The employee visited the emergency department and has been off work since then.

• Brand Name: ACCELERATOR A 3600
• 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: 17955313
• Report Number: 3010825766-2023-00011
• Device Sequence Number: 20584756
• Product Code: CEM
• UDI-Device Identifier: 07640172341001
• UDI-Public: (01)07640172341001(11)200604
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial
• Report Date (Section B): 10/18/2023

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: 09/18/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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