MAUDE Adverse Event Report: BIOMERIEUX S.A. CHROMID® SALMONELLA AGAR; CHROMID SALMONELLA 20 PLATES - 43621

Catalog Number 43621

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of no growth observed for a salmonella bredeney strain when testing an external qc strain with chromid® salmonella plates (ref 43621, lot 1007614530).As this was an external qc sample, there is no patient involved.The customer stated that no growth was observed when testing the proficiency strain on chromid® salmonella agar while pcr gave a positive result.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint for no growth observed for a salmonella bredeney strain when testing an external qc strain with chromid® salmonella plates (ref 43621, lot 1007614530).The strain was not able to be submitted for investigational testing.All quality control tests for lot 1007614530 (macroscopic appearance, ph measures and microbiological performance, including esterase activity detection) met specification.The recovery rate for all positive controls and the intensity of color due to esterase activity were within qc specifications.In addition to the retained sample of the implicated lot, other lots of chromid® salmonella at different ages from manufacturing date were tested in parallel.Lot: 1007781820 exp.Date: 01may2020.Lot: 1007718150 exp.Date:02apr2020.Lot: 1007644750 exp.Date:26feb2020.Lot: 1007552790 exp.Date:15jan2020.Routine strains (salmonella paratiphy a atcc 9150, salmonella paratiphy b atcc 10719, salmonella typhimurium atcc 14028, salmonella enteriditis atcc 13076) and salmonella ser.Bredeney api number (b)(4) were tested and obtained good results regarding growth and color (esterase activity).The customer's no growth issue was not reproduced internally.A review of complaints for the impacted lot (1007614530) since its release indicated that no others complaints were registered.The investigation concluded that the impacted lot (1007614530) complies with specifications.See h10 for addtl mfg narrative.

• Brand Name: CHROMID® SALMONELLA AGAR
• Type of Device: CHROMID SALMONELLA 20 PLATES - 43621
• Manufacturer (Section D): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 9527629
• MDR Text Key: 217436512
• Report Number: 9615755-2019-00021
• Device Sequence Number: 1
• Product Code: JSI
• UDI-Device Identifier: 03573026118877
• UDI-Public: 03573026118877
• 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: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2020
• Device Catalogue Number: 43621
• Device Lot Number: 1007614530
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1