MAUDE Adverse Event Report: BIOMÉRIEUX ITALIA S.P.A EASYMAG® INSTRUMENT

Model Number 200111

Device Problem Failure to Back-Up (1047)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

On (b)(6) 2023, a customer in united states notified biomérieux of delayed results due to firmware error after using easymag® (ref.200111, serial number (b)(6)) with patient samples.The customer reported an error regarding the movement of the heater (error 13002) leading to a failure to run tests.The customer stated that the issue was resolved with running the protocol 11 and there was no more firmware error.This issue led to a delay in rendering results of 2 days.There was no indication or report from the laboratory that the issue led to any adverse event related to patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An internal investigation was performed following a notification from a customer from united states that they obtained firmware error after using easymag® (ref.(b)(4), serial number (b)(6)).Investigation: the customer removed the involved samples and the instrument was restarted.The customer launched a water run and tried to run dummy samples, but the test failed again after 10 minutes with the same error.The issue was finally fixed after cleaning the nozzles and launching the maintenance protocol #11; indeed, after these actions, the firmware error no.13002 didn't occur anymore the maintenance protocol #11 (specific for the dbs (dry blood spot) extraction) fixed the issue, even if there is no direct relationship between this protocol and the firmware error n°13002 encountered.Since the firmware error n°13002 represents an isolated occurrence not reproduced anymore after the overall instrument cleaning, there was no possibility to further investigate and identify any specific component failure.Conclusion: investigation showed that the maintenance protocol #11 (specific for the dbs (dry blood spot) extraction) fixed the issue, even if there is no direct relationship between this protocol and the firmware error n°13002 encountered.Since then, no more issue was reported, and therefore there was no possibility to further investigate and identify any specific component failure.This issue was considered as an isolated event at the customer site.

• Brand Name: EASYMAG® INSTRUMENT
• Type of Device: EASYMAG® INSTRUMENT
• Manufacturer (Section D): BIOMÉRIEUX ITALIA S.P.A; via di campigliano 58 / loc. p; firenze 50012 ; IT 50012
• Manufacturer (Section G): BIOMERIEUX ITALIA S.P.A; via di compligliano 58 / loc.p; firenze 50012 ; IT 50012
• Manufacturer Contact: candace martin ; 595 anglum road; hazelwood, MO 63402
• MDR Report Key: 17144582
• MDR Text Key: 318084449
• Report Number: 9615037-2023-00004
• Device Sequence Number: 1
• Product Code: JJH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 200111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1