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

Device Problems Computer Software Problem (1112); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)

Event Type  malfunction  

Manufacturer Narrative

The distributor identified two scenarios.Cases of sample spillage from tubes filled more than the maximum filling volume: the tubes with urine sample are prepared manually, the cause can be attributed to a user error only.Cases of sample spillage from tubes filled at the filling volume: for this case the investigation is still ongoing to determine the root cause of the spillage.The customer also reported the presence on the track of several carriers with sample spillage residues which may prevent the carrier to correctly keep in position the sample tube during movements along the track.If the sample tubes are not correctly placed inside the carrier by a pick & place module, the tube can fall from the carrier.According to current design the automation system manages this event generating specific errors displayed on user interface.The errors "tube not detected" (error code sc04e) and "tube lost" (error code sc01e) are produced when at the downstream nodes the tube presence sensors see as empty a carrier which is expected to be full.The errors are evaluated sufficient to mitigate the risk of delayed sample processing without user notification.

Event Description

The customer reported cases of sample spillage from the tubes while they are moved by the robot of the auwi interface module from the analyzer rack to the carrier on the automation system track.The event may lead to cross-contamination of the other uncapped tubes that may be present in the area.The auwi analyzer processes urine sample tubes with nominal dimensions of 16mm (diameter) x 100mm (height).

Manufacturer Narrative

The initial mdr 3010825766-2019-00002 was filed on (b)(6) 2019.Additional information ((b)(6) 2019): the root causes of the sample spillage on the auwi interface modules have been identified.The sample spillage might occur only in case the robot interpolation is enabled and only if the tube moved by the robot is a stockwell ut-0001 urine tube.A new firmware version for the auwi system interface module has been released to reduce the maximum speed and the acceleration/deceleration on y and z robot's axis.The new firmware has been tested and it has been confirmed that it fixes the issue avoiding the sample spillage.The upgrade to the new firmware version is mandatory only in the site where the problem was reported since at present the auwi system interface module is installed only in this laboratory.No further evaluation of the device is required.

Manufacturer Narrative

The initial mdr 3010825766-2019-00002 was filed on march 6th, 2019.The mdr 3010825766-2019-00002 supplemental #1 was filed on july 23rd, 2019.Corrected data (july 24, 2019): the data reported in section g.4 of the mdr 3010825766-2019-00002 supplemental #1 has to be corrected: the date when the follow-up information has become available is june 26th, 2019.Refer to section g.4 of this report filled with the correct data.All the other information included in the previous reports is confirmed and, for this reason, not repeated also in this report.

• Brand Name: FLEXLAB
• Type of Device: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 8394890
• MDR Text Key: 141479623
• Report Number: 3010825766-2019-00002
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: K121012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: 02/04/2019; 06/26/2019
• Supplement Dates FDA Received: 07/23/2019; 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1