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

Catalog Number	43621
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: CHROMID SALMONELLA 20 PLATES - 43621
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 10028255
• Report Number: 9615755-2020-00007
• Device Sequence Number: 19672467
• Product Code: JWX
• UDI-Device Identifier: 03573026118877
• UDI-Public: 03573026118877
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2020
• Device Catalogue Number: 43621
• Device Lot Number: 1007807000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1