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

Device Problem Mechanical Problem (1384)

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

Event Date 04/18/2020

Event Type  malfunction  

Manufacturer Narrative

According to the investigation, the events of diluted secondary tubes not flagged with 2132 error are attributable to the dye which is not allowed according to the aliquoter pipettor instruction for use.The addition of liquids different from distilled water can damage the components of the aliquoter pipettor and can lead to inaccurate volumes during the aspiration and the dispensing.The cases of dilution after the addition of the dye are caused only by the inappropriate use of the aliquoter module.The distributor fse has changed the damaged parts, has removed the dye, has washed the aliquoter hydraulic circuit and has filled it with the correct liquid (distilled water).After these operations, the distributor fse confirmed that the aliquoter module is working according to specifics.As consequence of this event, inpeco is reviewing the message displayed on the graphic interface for the error 2132 to clarify to the user that the secondary sample flagged with this error may be diluted.Inpeco has planned a new training of the distributor regarding the new management of the clot detection error so that they can better inform the customers.

Event Description

Inpeco automation system includes the aliquoter module which is used to generate secondary sample tubes from the presented primary sample tube.In this laboratory the aliquoter module has been updated in accordance to recall currently in progress (res 85469).The upgrade includes the new management of the clot detection error: in case a clot detection error is generated during the aspiration, the sample is dispensed in the first available empty secondary tube.This secondary tube is flagged with a specific error (2132) and sent to a rack of the input output module to be manually managed by the operator.In case the aliquoter cannot aspirate the correct sample volume, it may dispense, besides the aspirated sample, also some distilled water of the aliquoter module hydraulic circuit.Since the customer was not aware of the new behavior of the aliquoter module, he suspected that the aliquoter module unexpectedly diluted the secondary tubes.To monitor the aliquoter module the distributor fse added a dye in the module hydraulic circuit.After this addition, on may 7th 2020, the customer reported other cases of dilution of secondary tubes also not flagged with 2132 error.Since these cases were not the expected behavior of the aliquoter module, they have been investigated by inpeco.

• Brand Name: FLEXLAB
• Type of Device: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• Manufacturer (Section G): INPECO SPA; via givoletto 15; val della torre, 10040 ; IT 10040
• Manufacturer Contact: eva balzarotti ; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 10122111
• MDR Text Key: 208127838
• Report Number: 3010825766-2020-00005
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other