MAUDE Adverse Event Report: BIOMERIEUX SA EMAG® SYSTEM

Model Number 4704256

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of potential contamination associated with emag® system (reference 470456).The customer reported that there was a potential contamination on a sample adjacent to an uls error sample on the emag system.Sample results on (b)(6) 2018 for batch z109gpbnm at 9:32 am left section: - vessel position 1.2 skin swab id = (b)(6) / error 1076 ultrasonic reading below threshold => not extracted.- vessel position 1.3 csf id = (b)(6) pcr amplification result altona: (b)(6).A second run extraction on the same two samples performed on (b)(6) 2018 at 15:38 vessel 1 position 1 and 2 no uls error on the skin sample altona amplification: (b)(6).Id = (b)(6) csf negative.There was no impact to the patient due to this issue.However, there was a delay in reporting results greater than 24 hours.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed for a customer who reported a suspicion of a contaminated sample with the emag® system (reference: (b)(4), when the sample was invalidated by ultra sound sensor (uss) error 10076.The investigation was performed on the customer site by the local field application specialist and r&d, using apu logs.When an error 10076 "ultrasound reading below threshold error(error on vessel)" occurs, the system aborts the associated well.There is no more buffer dispensed, and nothing from this well can be transferred inside other wells.The sample on which the contamination suspicion was made, was re-extracted and retested with the eluates of the first extraction.First eluate was positive twice to hsv1.New eluate was negative twice.This retest confirmed that the contamination happened at the extraction steps or pcr setup.The root cause of the contamination of the eluate was not identified.Note; causes of alarm 10076 could be due to leakage at aspirator level or tip clog.Conclusion: the root cause of the contamination was not identified : eluate was contaminated but investigation did not allow to find the step where this contamination was done (extraction or manual steps around pcr setup).We cannot exclude an environmental contamination of the lab as the lab has also reported a suspicion of lab contamination by hsv on their easymag which is under investigation.After an field service engineer intervention and a reminder on the good practices of cleaning a molecular lab and systems, the customer has not reported any additional contamination issues on this site.

• Brand Name: EMAG® SYSTEM
• Type of Device: EMAG® SYSTEM
• Manufacturer (Section D): BIOMERIEUX SA; via di campigliano; 58 - loc. ponte a ema; 50012 bagno a ripoli, ; IT
• MDR Report Key: 7771781
• MDR Text Key: 116718349
• Report Number: 3002769706-2018-00140
• Device Sequence Number: 1
• Product Code: JJH
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4704256
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1