MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID TM STAPH AUREUS AGAR; CHROMID STAPH AUREUS AGAR

Catalog Number 43371

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) reported inconclusive results for the staph aureus atcc strain (indicated in the instructions for use) in association with chromid tm staph aureus agar (ref.43371, lot 1004085400).Though green colonies are the correct indication for a staph aureus organism, the customer claims the observed light green colony color is not typical compared with the other lot numbers used in the past.Evaluation during the troubleshooting activities by biomerieux support determined the referenced lot number was placed on stop order by biomerieux and is associated with a field corrective action.There is no indication or report from the hospital or treating physician to biomerieux that the inconclusive result led to any adverse event related to a patient's state of health.No patient was directly associated with the atcc strain result.Strain submittals have been requested by biomerieux for internal investigation.

Manufacturer Narrative

Biomérieux internal investigation was initiated.Evaluation of the qc batch records for the release of chromid tm s aureus agar lot 1004085400 indicates performance in accordance with specifications after 20 hours and 24 hours of incubation at 33-37 ° c.This lot was the subject of stop shipment ((b)(4), issued 07aug15) and field safety corrective action (fsca-2624, issued 19aug15) due to ingredient discrepancy in the dry environment of the formula used in the manufacture of the lot.This discrepancy can induce slower or weaker staining of s.Aureus strains.Customers were instructed to discard the incriminated product lot.A capa was initiated to determine the root cause of the raw material mixture in the dry environment and define the corrective and preventive actions.Testing was performed on the agar plates submitted by the client.Three (3) staphylococcus aureus strains were tested: atcc 6538 and 13150 gave characteristic colonies at 24 hours, atcc 25923 gave characteristic colonies at 48 hours.The issue described by the customer was not confirmed with the chromid s aureus plates submitted by the customer.

• Brand Name: CHROMID TM STAPH AUREUS AGAR
• Type of Device: CHROMID STAPH AUREUS AGAR
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• Manufacturer (Section G): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5072147
• MDR Text Key: 25628505
• Report Number: 3002769706-2015-00083
• Device Sequence Number: 1
• Product Code: JWX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: CL. I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Report Date: 08/07/2015

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: 10/07/2015
• Device Catalogue Number: 43371
• Device Lot Number: 1004085400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1