MAUDE Adverse Event Report: BIOMERIEUX SA CHROMID (TM) SA; CHROMID(TM) SA

Catalog Number 43371

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

Customer called to report weak growth of staphylococcus aureus strain on chromid(tm) staphylococcus aureus, ref.(b)(4), lot 1004235150.Colonies were yellow with no change after 24 hours incubation (green is expected).Customer retested strain with (s.Aureus atcc 25923 tm) and received the same results.No incorrect results were provided to physicians as they use a second method (latex and coagulase) to confirm results.

Manufacturer Narrative

Biomérieux investigation was conducted in association with chromid tm s.Aureus agar, due to false negative result.Evaluation of the batch records for the implicated lot indicate no discrepancies detected during manufacturing.The results of microbiological quality control were in accordance with specifications.Investigational testing activities included: customer batch of chromid tm s.Aureus agar.Random batch of chromid tm s.Aureus agar.Same strains used during the release tests for the batch.After an incubation of 20-24h, the s.Aureus strain atcc 6538 presents dark green colonies (positive for s.Aureus), with the same results for each batch.The s.Aureus strain atcc 25923 presents green colonies in the mass, but some isolated colonies are pale green to colorless for the random batch and colorless for the customer batch.After an incubation of 48h all the results are correct for each batch: good growth of staphylococcus aureus atcc 25923 with characteristic green colonies.Good growth of staphylococcus aureus atcc 6538 with characteristic green colonies.The investigation concluded that the performance of chromid tm s.Aureus agar (b)(4) is within specifications.The issue reported by the customer could not be duplicated.

• Brand Name: CHROMID (TM) SA
• Type of Device: CHROMID(TM) SA
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5126994
• MDR Text Key: 27857509
• Report Number: 3002769706-2015-00112
• Device Sequence Number: 1
• Product Code: JWX
• Combination Product (y/n): N
• 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
• Type of Report: Followup
• Report Date: 09/15/2015

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: 12/11/2015
• Device Catalogue Number: 43371
• Device Lot Number: 1004235150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1