MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID® S.AUREUS ELITE; CHROMID S.AUREUS ELITE 20 PL - 419042

Catalog Number 419042

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 16-apr-2020, a (b)(6) customer reported absence of typical pink coloration when growing s.Aureus strains with chromid s.Aureus elite 20 pl, reference 419042, lot 1007883410, expiry date 29-may-2020.The customer reported that typical pink colored colonies for a s.Aureus patient strain were not observed as expected.The same strain showed pink colonies on a lot number previously used by the customer.The customer subsequently subcultured the same s.Aureus patient strain on two different lot numbers of reference 419042 and on blood agar in parallel.On lot 1007883410, colonies are beige-yellow and on a different lot number, colonies are pink-purple as expected for s.Aureus.The customer also observed this issue on others samples (blood cultures or orthopedic wound samples).There is no indication from the customer that this event impacted the patient state of health or led to a delay of results.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in france regarding the absence of typical pink coloration when growing s.Aureus strains with chromid s.Aureus elite 20 pl (reference 419042, lot 1007883410).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.See section h10.

• Brand Name: CHROMID® S.AUREUS ELITE
• Type of Device: CHROMID S.AUREUS ELITE 20 PL - 419042
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 10028243
• MDR Text Key: 209226624
• Report Number: 9615755-2020-00006
• Device Sequence Number: 1
• Product Code: JSI
• UDI-Device Identifier: 03573026494445
• UDI-Public: 03573026494445
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2020
• Device Catalogue Number: 419042
• Device Lot Number: 1007883410
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1