MAUDE Adverse Event Report: BIOMERIEUX S.A. CHROMID® VRE ID AGAR

Catalog Number 43004

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018, a customer in (b)(6) reported a no growth result obtained on (b)(6) 2018, for a vancomycin resistant enterococcus faecium eeq quality control survey strain, in association with chromid® vre id agar (lot.# 1006476480, expiry 30jul2018).The customer stated that no growth was observed after 24 and 48 hours of incubation at 37°c.The agar was stored at 2-8°c protected from the light.No quality control was performed.There was no patient involvement as the event pertained to a quality control sample.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed for a false negative result for an enterococcus faecium eeq quality control survey strain, in association with chromid® vre id agar (lot.# 1006476480, expiry 30jul2018).A review of manufacturing and quality records confirmed that lot 1006476480, conformed with all specifications and all quality controls including microbiological activity.Non-conformities and deviations were not detected on this lot.As the impacted lot 1006476480 was already expired at the moment of the investigation, retained kit from another reference lot was tested with quality control strains.Reference lot 1006983950,was tested with the atcc strains enterococcus faecalis (atcc 51299) and enterococcus faecium (atcc 700221).The results were conforming and within specifications.The strain received from the customer, was tested with a plate from retained kit of the reference lot 1006983950.The result was good growth, after 24 and 48 hours of incubation, of typical violet colonies characteristics of an enterococcus faecium strain, resistant to vancomycin (vre strain).The absence of growth from this strain observed by the customer was not reproduced.The complaint review showed that no other complaint was received for the lot 1006476480.In conclusion, chromid® vre id agar (lot.# 1006476480) performed as expected.

• Brand Name: CHROMID® VRE ID AGAR
• Type of Device: CHROMID® VRE ID AGAR
• Manufacturer (Section D): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne, 69290 ; FR 69290
• MDR Report Key: 7965728
• MDR Text Key: 126090750
• Report Number: 3002769706-2018-00215
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• PMA/PMN Number: K091025
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2018
• Device Catalogue Number: 43004
• Device Lot Number: 1006476480
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1