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

Device Problem Device Issue (2379)

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

Event Date 02/06/2017

Event Type  malfunction  

Manufacturer Narrative

The event was investigated by inpeco, which determined that the abnormal number of clot detection errors and the samples dilution were due to a lack of maintenance of the aliquoter tubing system.The aliquoter service manual is referenced in the flexlab service manual: the maintenance instructions clearly indicates the frequency of aliquoter tubing system replacement according to the time passed since the installation or the previous replacement or the operating hours.The malfunction was not due to the aliquoter module design.This device is performing according to specifications.No further evaluation of this device is required.

Event Description

The distributor service team has been contacted by the laboratory personnel due to an abnormal number of clot detection errors on samples processed on aliquoter module #1 (aqm # 1) connected to flexlab product.During the troubleshooting a video was taken to aid with identifying the cause of the problem: it was determined from the video that water from the aqm #1 pipettor circuit was being dispensed into the sample tubes.The laboratory personnel and the distributor service team identified 175 primary sample tubes and 118 secondary sample tubes diluted due to the aliquoter module #1 malfunction.There was no death neither serious injury to any patient due to erroneous test results.As immediate actions the aliquoter module #1 was set off-line and the tests were re-executed on alternate sample tubes.

• Brand Name: FLEXLAB
• Type of Device: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via san gottardo 10; lugano, ticino 6900 ; SZ 6900
• Manufacturer (Section G): INPECO S.P.A.; via givoletto 15; val della torre (torino), 10040 ; IT 10040
• Manufacturer Contact: giorgia amabile ; via san gottardo 10; lugano, ticino 6900 ; SZ 6900
• MDR Report Key: 6379770
• MDR Text Key: 69097120
• Report Number: 3010825766-2017-00001
• 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: company representative,distri
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 03/06/2017

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2017
• Initial Date FDA Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1