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

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 08/30/2023

Event Type  Death  

Manufacturer Narrative

From inpeco log analysis the sample tube (b)(6) was managed as follows: - at 21:28 (according to the information provided by the user) the sample has been collected.- from 21:28 to 22:09 no loading action were performed by the bim.The bim was always online with no errors.- at 22:09 the bim finished loading the tubes in the hopper by reporting 0727, loading completed (a warning message posted on software interface to inform the user to check the tray, the belts and the loading area for possible residual sample tubes).The tube (b)(6) was not loaded during this action but other 2 tubes of the same patient with other tests were successfully loaded.Note: by design the bim has a sensor to detect the sample tubes loaded inside the bin and to activate the hopper which remains active for a timeframe after the detection of the last sample tube in order to allow the sample tube loading on the automation track.- at 22:35 the order for d dimer test was received from lis as routine sample (not as priority sample).Note: without the order reception by the lis no test can be performed on the tubes.- at 23:49 there was the check in of the sid (b)(6) on the automation system.Also in the timeframe between the warning 0727 and the sample check-in at 23:49, the bim remained online without any error.The time of the arrival of the sample tube from the third-party pneumatic tube system is not logged on inpeco system and it is unknown.- the sample tube has been centrifuged at 00:02, decapped at 00:03 and sampled by the analyzer at 00:05.- result for d dimer test was received from the instrument and sent to lis at 0:19.The obtained result was mg/l which means that the analysis failed.There were 3 other sample tubes of the same patient with additional test orders received at 22:35.Prior the obtainment of d dimer result, the sample tube for clinical chemistry was tested and the result obtained for troponin (48.9 ng/l) and sent to lis at 23:20 showed symptoms of myocardial damage.The distributor has provided pictures of the impacted module: inside the module bin a piece of adhesive tape was visible at the bottom of the bin, this modification is not allowed by inpeco design.The investigation is still ongoing to determine if inpeco product contributed to cause the adverse event.

Event Description

The customer reported that a sample tube sid (b)(6) remained inside the bulk input module (bim) until the user noticed it and the result for the d dimer test was received after more than 3 hours from the blood sample.In the meanwhile, the patient died of a heart attack.The bim allows direct loading on the track of sample tubes loaded in bulk into the module not allowing specific loading sequence.In this laboratory the sample tubes are loaded inside the bim by a third-party pneumatic tube system.

Manufacturer Narrative

The initial mdr (3010825766-2023-00012) was submitted on october 18th, 2023.Additional information: the automation logs highlight an incorrect clinical management by the laboratory operators of the tubes pertaining the patient since the sample tubes were loaded before the test orders were received from lis.From an hw perspective and the information provided, it's not possible to confirm whether tube with dimer test was stuck in the bim since: the third party pneumatic system does not have any log to record the discharge of tubes into the bim.No tube events in sms logs are generated before the tube is loaded into the automation system finally, unauthorized actions (e.G.Tape inside the tray) have tampered with the bim design and the sensor cables have been replaced with unofficial spare parts.As a result, inpeco cannot guarantee the module's correct operation.The distributor has installed a new bim hopper with sensor and cable restoring the correct design.No additional actions have been evaluated necessary.

• 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: 17956511
• MDR Text Key: 325918559
• Report Number: 3010825766-2023-00012
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death