MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID SALMONELLA AGAR; CHROMID SALMONELLA 20 PLATES - 43621

Catalog Number 43621

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

On (b)(6) 2020, an (b)(6) customer reported atypical coloration when testing salmonella strain with chromid salmonella 20 plates - reference 43621, lot 1007807000, expiry date 22-may-2020.The customer didn't obtain the correct characteristic colony color on 3 different samples.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in austria regarding atypical coloration when testing a salmonella strain with chromid salmonella - reference (b)(6), lot 1007807000, expiry date 22-may-2020.An internal investigation was conducted using biomerieux retained samples of the subject lot, and on the plates received from the customer.The testing results confirmed the product performed within expected specifications.The customer issue was not reproduced through the internal investigation performed on the retain samples, nor with the customers plates provided.A root cause of the event could not be established.

• Brand Name: CHROMID SALMONELLA AGAR
• Type of Device: CHROMID SALMONELLA 20 PLATES - 43621
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 10028255
• MDR Text Key: 209224348
• Report Number: 9615755-2020-00007
• Device Sequence Number: 1
• Product Code: JWX
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2020
• Device Catalogue Number: 43621
• Device Lot Number: 1007807000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/17/2020
• Initial Date FDA Received: 05/06/2020
• Supplement Dates Manufacturer Received: 07/06/2020
• Supplement Dates FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1