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

Model Number AP2

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation performed by the product distributor reported that an hardware problem was detected in the pipettor valve and pump of the aliquoter module.The aliquoter module behavior described by the customer is not consistent with the behavior foreseen with the aliquoter firmware version installed on site: in case of problem with the aliquoting process, the sample should be re-dispensed in the first available empty secondary tube, not in the primary tube.Then, both the primary and secondary tubes are flagged with error and sent to the priority output to be manually inspected and managed by the laboratory operator.The investigation is still ongoing.The customer did not report any impact on patient care due to the event.As immediate action, the product distributor replaced the failed pipettor valve and pump.The investigation is still ongoing.

Event Description

The customer notified a malfunction of the aliquoter module: the customer supposed that, in case of "clot detection error", a little amount of water from the aliquoter hydraulic circuit may be dispensed into the primary tube leading to sample dilution.

Manufacturer Narrative

Information reported on july 29th, 2020: inpeco supposed two possible options: the complaint is inconsistent because the aliquoter module behavior is not the expected one by design, so the customer might has wrongly described the scenario; otherwise, it is possible that the software version of the aliquoter module has not been updated properly by the product distributor service personnel (fse), and this would explain the discrepancy of the behavior.This scenario would be singular since: the service personnel is a trained person, the instructions provided to service personnel have been reviewed and they are considered adequate, no other similar events from the field.It was not possible to identify exactly which of the two options was the cause of the event, but the fse confirmed that at present the aliquoter module versions are the expected ones, and the event has not occurred anymore.No further actions foreseen by inpeco, since according to the investigation results stated above, there is not need of a product design change.

• Brand Name: APTIO AUTOMATION
• Type of Device: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 9503932
• MDR Text Key: 189867393
• Report Number: 3010825766-2019-00012
• Device Sequence Number: 1
• Product Code: CEM
• UDI-Device Identifier: 07640172342008
• UDI-Public: (01)07640172342008(11)180730
• 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
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

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
• Device Model Number: AP2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 07/07/2020
• Supplement Dates FDA Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1