MAUDE Adverse Event Report: BIOMERIEUX S.A. CHROMID® MRSA SMART AGAR

Catalog Number 413051

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a false negative result for a neqas survey strain of staphylococcus aureus in association with the chromid® (b)(6) smart agar (reference 413051, lot 1007281820).The customer also tested the neqas strain using the vitek®2; the cefoxitin screen test and benzylpenicllin minimum inhibitory concentration results indicate this survey strain in (b)(6).Though chromid® (b)(6) smart agar (reference 413051) is not registered, marketed of distributed in the u.S., a similar product chromid® (b)(6) agar (reference 43841) is registered in the u.S.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.Biomérieux will initiate an internal investigation.

Manufacturer Narrative

An investigation was completed in response to a customer complaint for a false negative result for a neqas survey strain of staphylococcus aureus in association with the chromid® mrsa smart agar (reference 413051, lot 1007281820).The same neqas strain (distribution 4490, specimen (b)(6)) was available internally for investigational testing.The neqas sample was re-suspended following the instructions from neqas and the identification was confirmed as staphylococcus aureus using the vitek® ms sytem.Since chromid® mrsa smart agar (reference 413051, lot 1007281820) was expired before the investigation, a different lot that was manufactured with the same dry media formulation was tested (lot 1007448710).The investigation lot (1007448710) was inoculated with the neqas strain according to the quality control protocol and good growth and characteristic color was obtained.The customer's false negative result was not reproduced internally when the same survey strain was tested on a lot with the same formula as the lot used by the customer.A review of complaints indicated that no other complaints were registered on the implicated lot number (1007281820).A review of complaints related to reference product 413051 indicated that no other complaints were recorded for this neqas sample (distribution 4490, specimen (b)(6)).Manufacturing records and quality control testing were reviewed for lot 1007281820 and the lot met all acceptance criteria.No product performance issues were identified during the investigation.

Manufacturer Narrative

Correction to additional information provided in supplement 1.Incorrect lot number (1007448710) was listed for lot used during investigational testing.Correct information: lot: 1007561970.Expiry: 08-nov-2019.Date of manufacture: 30-aug-2019.Changed from: since chromid® mrsa smart agar (reference 413051, lot 1007281820) was expired before the investigation, a different lot that was manufactured with the same dry media formulation was tested (lot 1007448710).The investigation lot (1007448710) was inoculated with the neqas strain according to the quality control protocol and good growth and characteristic color was obtained.Changed to: since chromid® mrsa smart agar (reference 413051, lot 1007281820) was expired before the investigation and no other lots manufactured with the same dry media formulation were available.Lot 1007561970 (expiry date: 08-nov-2019) was used for investigational testing.The investigation lot (1007561970) was inoculated with the neqas strain according to the quality control protocol and good growth and characteristic color was obtained.

• Brand Name: CHROMID® MRSA SMART AGAR
• Type of Device: CHROMID® MRSA SMART AGAR
• Manufacturer (Section D): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne, 69290 ; FR 69290
• MDR Report Key: 8803355
• MDR Text Key: 207924000
• Report Number: 9615755-2019-00005
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• PMA/PMN Number: K091024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2019
• Device Catalogue Number: 413051
• Device Lot Number: 1007281820
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1