MAUDE Adverse Event Report: BIOMERIEUX SA CHROMID® VRE AGAR

Catalog Number 43004

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of media shrinkage after incubation with chromid® vre (reference (b)(4)).The customer stated that no wrong results were reported to a physician, and there was no incorrect patient treatment or patient harm due to the media shrinkage.However, the customer stated that some of the results were delayed 48 hours.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in sweden notified biomérieux of media shrinkage after incubation with chromid® vre (reference 43004).An investigation was performed.The customer reported that the manufacturing time on the impacted plates was 17:23 hours, and the product was stored in the fridge in the original plastic wrapping for one week.The customer provided photos of the impacted plates, in which 40 plates in total were affected.Lot number record analysis: lot number 1006199280 was manufactured in accordance with specifications.Quality control records for microbiological state, appearance, and activity, confirmed the product performed and conformed to specifications.Retained samples analysis: biomérieux tested retained samples for the impacted lot number.Plates manufactured at different times (14:27, 15:06, 15:23, 16:23, 16:52, 17:34) were inspected for shrinkage defects which were not detected.The plates were then incubated for 24 hours and 48 hours at 35°c.After incubation, there was no media shrinkage for all plates tested.Conclusion: the lot number records and retained samples analysis complied with specifications.The customer's issue was not observed.The reported media shrinkage after incubation can be considered as an isolated event for the plates received.

• Brand Name: CHROMID® VRE AGAR
• Type of Device: CHROMID® VRE AGAR
• Manufacturer (Section D): BIOMERIEUX SA; 5 rue des aqueducs; craponne, 69290 ; FR 69290
• MDR Report Key: 7346326
• MDR Text Key: 103167154
• Report Number: 3002769706-2018-00043
• 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: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2018
• Device Catalogue Number: 43004
• Device Lot Number: 1006199280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 03/16/2018
• Supplement Dates Manufacturer Received: 06/07/2018
• Supplement Dates FDA Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1