MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® RUB IGG II

Catalog Number 30221

Device Problem Use of Device Problem (1670)

Patient Problem Chemical Exposure (2570)

Event Date 07/06/2018

Event Type  Injury  

Event Description

A customer from (b)(6) notified biomérieux of an operator exposure occurring on (b)(6) 2018 when using the product vidas® rub igg ii ((b)(4)).Although reference (b)(4) rub igg ii is not registered in the us, a similar device, reference (b)(4) rub igg is approved for the us.When the operator removed the solid phase receptacle (spr) from the spr block at the end of analysis, she was exposed to a drop from the spr in her eye.The sample tested during this run came from a pregnant woman tested for rub igg (positive) and also (b)(6).The operator consulted an ophthalmologist with the material safety data sheet (msds) of the substrate of this test the same day of the incident: no lesion in the eye was observed.A treatment wash with dacudose and vismed was prescribed.The physician considered the risk as low regarding the (b)(6) transmission, because the eye is not a mucosa sensitive to viruses.The operator complained of left eye burning for two days.The msds for this product states that the substrate is an irritant for eyes and can cause serious eye damage.The package insert states as a precautionary statement to wear eye protection.The operator was not wearing eye protection when the incident occurred.Also to be noted, the incident occurred at the end of the test run; therefore, there should have been no patient sample remaining in the spr due to several washing steps.The exposure should have been to the test substrate only.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An internal investigation was performed for an event occurring on (b)(6) 2018 when an operator was exposed to a drop of serum in their eye, during the removal of the solid phase receptacle (spr) when using the product vidas® rub igg ii (ref 30221) lot 1006180020/181211-0 (11dec2018 expiry).The operator was not wearing eye protection when the incident occurred.No other complaint was registered for operator injury, visual defect or breakage of reagents with vidas rbg ii.No capa nor non conformity is linked to the customer's issue.No anomaly during the manufacturing, control and packaging processes linked to the customer's issue.Instruction for use package insert: warnings and precautions.Precautionary statement: wear protective gloves/protective clothing/eye protection/face protection.If in eyes: rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do.Continue rinsing.For further information, refer to the material safety data sheet.Msds instructions.Precautionary statements.Prevention: wear protective gloves/protective clothing/eye protection/face protection.Conclusion : operator should be made aware about the importance of wearing personal protective equipment.Performances of vidas rbg lot 1006180020/ 181211-0 and of the vidas system were not in question.

• Brand Name: VIDAS® RUB IGG II
• Type of Device: VIDAS® RUB IGG II
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• MDR Report Key: 7767896
• MDR Text Key: 116717566
• Report Number: 3002769706-2018-00138
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• PMA/PMN Number: K080766
• 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: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2018
• Device Catalogue Number: 30221
• Device Lot Number: 1006180020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 08/24/2018
• Supplement Dates FDA Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention