MAUDE Adverse Event Report: BIOMERIEUX SA CHROMID® S 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 france notified biomérieux of a discrepant result associated with chromid® s.Aureus agar (reference (b)(4)).The customer reported an absence of growth for a s.Aureus strain after 48 hours of incubation.The strain was isolated on cos anc media.The customer indicated that the false result was not reported to a physician; however, the result was delayed for 24 hours.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) notified biomérieux of a discrepant result associated with chromid s.Aureus agar (reference 43371) involving absence of growth for a s.Aureus strain after 48 hours of incubation.An internal biomérieux investigation was performed with results as follows: retention sample of customer's lot (1004624450) and two random lots (1004639390/same manufacturing date and 1004875030/recent manufacture date) were tested with strains s.Aureus atcc 25923, s.Aureus atcc 6538, s.Xylosus atcc 29971 and s.Saprophyticus atcc 15305.Results- after 18-24 hour incubation at 33-37° c, the performance was within specifications for all strains without differences between lots regarding: numeration, size of colony and intensity of color.S.Aureus atcc 25923 and s.Aureus atcc 6538 produced the expected colony appearance.Both developed a spontaneous green coloration whereas, s.Xylosus atcc 29971 and s.Saprophyticus atcc 15305 were not able to produce glucosidase activity.Complaint trending was reviewed; no critical issues regarding product performance were detected.Review of raw data related to manufacturing process and quality control steps was performed.All specifications met and no observations or non-conformities found that could explain the performance problem reported by the customer.Biomérieux requested the strain from the customer; however, it was not possible to submit the strain.Based upon the results of the internal investigation, chromid s.Aureus agar is performing in accordance with product specifications.

• Brand Name: CHROMID® S AUREUS AGAR
• Type of Device: CHROMID® S AUREUS AGAR
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5667095
• MDR Text Key: 45527271
• Report Number: 3002769706-2016-00090
• Device Sequence Number: 1
• Product Code: JWX
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 05/12/2016

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: 05/23/2016
• Device Catalogue Number: 43371
• Device Lot Number: 1004624450
• Is the Reporter a Health Professional?: Yes
• Event Location: Outpatient Diagnostic Facility
• Initial Date Manufacturer Received: 05/12/2016
• Initial Date FDA Received: 05/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1