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 05/17/2017

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 an incorrect maintenance of the aliquoter unit.Specifically, the user did not use distilled or de-ionized water as clearly indicated in the service manual.As a consequence, aliquoter unit components were damaged.As corrective action the distributor has replaced the damaged aliquoter unit components.The relevant part of the service manual has been reviewed and it has been confirmed the instructions are clear and not misleading.The product design and labeling are considered adequate.No product change foreseen.This device is performing according to specifications.No further evaluation of this device is required.

Event Description

Inpeco was notified by the flexlab distributor about an issue with the aliquoter unit.Specifically, a small volume of water from the aliquoter pipettor circuit was dispensed into sample tubes diluting them.The distributor referred also that the customer experienced an unexpected increased number of errors (i.E.Clot detection error) the days before the event.As immediate action the distributor set the aliquoter module off-line.Inpeco reviewed the log files and identified the sample tubes processed by aliquoter potentially affected by dilution.The list of samples id was communicated to the customer in order to let them double check the tests result.There was no death neither serious injury to any patient due to erroneous test results.

• 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: eva balzarotti ; via san gottardo 10; lugano, ticino 6900 ; SZ 6900
• MDR Report Key: 6645998
• MDR Text Key: 77870182
• Report Number: 3010825766-2017-00003
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K121012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Service Personnel
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/16/2017

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: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2013
• 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