MAUDE Adverse Event Report: BIOMÉRIEUX ESPAÑA CHROMID® STAPH AUREUS

Catalog Number 43371

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An investigation into a false negative event while using the chromid® staph aureus plates was performed.The chromid® staph aureus failed to grow a qc-strain on multiple attempts.A complaint trend review was performed on this lot.No other similar complaints have been received.Four atcc® quality control samples (atcc® 2593, atcc® 6538, atcc® 29971, and atcc® 15305) were inoculated onto retain plates from the implicated lot as well as 4 lots from varying expiry dating, similar to implicated plates, at expiry, middle of shelf-life, and freshly manufactured.Additionally, customer returned samples were inoculated with the same atcc® quality control samples.All plates inoculated grew the organism as expected.Based on the results of the investigation, the complaint could not be confirmed and the product is operating within specifications.

Event Description

A customer reported to biomerieux a discrepant result event occurred when using the chromid® staph aureus plate.The customer reported that a quality control sample failed to grow on the chromid® staph aureus plate.The customer did repeat the quality control sample twice with the same results of no growth observed.Since the incident involved quality control samples and not patient samples, no adverse impact to the patient or delay in results was experienced.An investigation has been initiated by biomerieux to investigate this event.

• Brand Name: CHROMID® STAPH AUREUS
• Type of Device: CHROMID® STAPH AUREUS
• Manufacturer (Section D): BIOMÉRIEUX ESPAÑA; isaac newton, 6; tres cantos; madrid, spain 28760 ; SP 28760
• Manufacturer (Section G): BIOMÉRIEUX ESPAÑA; isaac newton, 6; tres cantos; madrid, spain 28760 ; SP 28760
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5924147
• MDR Text Key: 53791290
• Report Number: 3002769706-2016-00162
• Device Sequence Number: 1
• Product Code: JWX
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/08/2016

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: 10/04/2016
• Device Catalogue Number: 43371
• Device Lot Number: 1004942170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2016
• Initial Date FDA Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1