MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® MEASLES IGG ASSAY

Catalog Number 30219

Device Problems Fluid/Blood Leak (1250); Device Damaged Prior to Use (2284)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomérieux to report they observed a leaking vial for the control 1 reagent contained in a vidas® measles igg assay kit.The customer stated that no personnel were harmed as a result of the leaking vial.The user was reminded of the proper precautions regarding personal protective equipment when handling the vial.Though the associated msds indicates "no dangerous reaction known under conditions of normal use", it also states products contained within the kit can cause serious eye damage/irritation.The package insert for the product states "wipe up spills thoroughly after treatment with liquid detergent and a solution of household bleach containing at least 0.5% sodium hypochlorite (10% bleach) to inactivate infectious agents.Evaluation of complaint records indicates no other reports of leaking vidas® measles igg control vials.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) contacted biomérieux to report they observed a leaking vial for the control 1 reagent contained in a vidas® (b)(6) igg assay kit.An internal biomérieux investigation was performed.The complaint concerns the vidas® msg lot 1004735420 / 170201-0.Upon the opening of the box, the customer found the c1 vial vidas® msg lot 1116180 reversed and badly screwed with a leak.The analysis of batch history records of vidas® msg lot 1004735420 / 170201-0 showed no anomaly during the packaging.The analysis of batch history records of the c1 vial vidas® msg lot 1116180 showed no anomaly during the filling.The quality control performed a serological control on vidas® msg c1 lot 1116180.(b)(6) serology and the results were (b)(6) as mentioned in the package insert."this product has been tested and shown to be (b)(6) for (b)(6) surface antigen, and antibodies to (b)(6).However, since no existing test method can totally guarantee their absence, this product must be treated as potentially infectious.Therefore, usual safety procedures should be observed when handling".The quality control laboratory checked the retain kit vidas® msg lot 1004735420 / 170201-0: the vials were correctly screwed.There is no other complaint on the vidas® msg lot 1004735420 / 170201-0 for the same issue.There is no capa or non-conformity for a similar issue.The quality product laboratory recommend to the customer to wear gloves when handling reagents in accordance with good laboratory practices.A communication to the filling department will be performed informing them about this complaint.

• Brand Name: VIDAS® MEASLES IGG ASSAY
• Type of Device: VIDAS® MEASLES IGG ASSAY
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6067731
• MDR Text Key: 58851968
• Report Number: 3002769706-2016-00456
• Device Sequence Number: 1
• Product Code: LJB
• Combination Product (y/n): N
• PMA/PMN Number: CL. I 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: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2017
• Device Catalogue Number: 30219
• Device Lot Number: 1004735420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1