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

Model Number	AP2
Medical Device Problem Codes	Mechanical Problem (1384); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to a no longer valid occupation code (initial importer occupation) the emdr was not correctly saved in the cdrh's adverse event database.All the other data are confirmed.
Event or Problem Description
The product distributor has notified inpeco that stop gates become "stuck" and track jams and splashing occurs.The sample splash from tubes may cause cross contamination.The covers avoid that the operators can come in contact with the spilled sample.Note: the stop gate is the gate on the automation main track which is activated to temporary stop the sample carriers routing to allow the sample carrier return from the module/interface module buffer to the main track.
Additional Manufacturer Narrative
Upon inpeco request, the pistons supplier provided a report with the problem analysis and root cause, that was then reviewed and acknowledged by inpeco.Some batches of the pistons have been treated with a grease not foreseen by design.The use of a wrong grease was due to an human error (supplier personnel error) during manufacturing process.The pistons with the wrong grease, depending of grease quantity and working condition, have a higher probability to behave closer to the acceleration boundary, and may lead to an activation of the gate not synchronized with the sample carrier passage.The pistons supplier informed inpeco that the correct production process has been restored: the wrong grease has been removed on every work place that produce the pistons, and working instructions has been updated to prevent re-occurrence of the problem.The pistons treated with the non-conforming grease have not been evaluated as defective, since they have just an higher probability to behave closer to the acceleration boundary: the gates equipped with these pistons work according to design specifications.For this reason, it is not required the replacement on the field of the gates with the non-conforming grease, and inpeco evaluated that a field safety corrective action is not needed.No injury to patient was reported from the customer.No other similar event that led to sample spillage was reported from the field.No further investigation is required.

• Brand Name: APTIO AUTOMATION
• Common Device Name: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, ticino 6883 ; SZ 6883
• MDR Report Key: 8173266
• Report Number: 3010825766-2018-00001
• Device Sequence Number: 19553049
• Product Code: JQP
• UDI-Device Identifier: 07640172342008
• UDI-Public: (01)07640172342008(11)180405
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AP2
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 04/02/2019
• 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