MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID(TM) MRSA

Catalog Number 43451

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

A customer in (b)(6) reported a false negative result while using the (b)(6) test kit.

Manufacturer Narrative

An investigation into a (b)(6) event while using the chromid(tm) (b)(6) test kit was performed.The customer was unable to return the impacted patient samples; therefore, testing on the patient sample was unable to be performed.Retain samples from the lot in question as well as another lot were tested with an atcc strain of (b)(6).All retain kits produced the appropriate result and demonstrated the lots were performing as expected.A review of the production batch record was performed.No anomalies or deviations were noted that could cause or contribute to the discrepant result.A review of complaint files for the lot in question was performed.No other related complaints were found for this lot.Based on the results of the investigation, the complaint could not be confirmed and the product is operating as intended and within specifications.

• Brand Name: CHROMID(TM) MRSA
• Type of Device: CHROMID(TM) MRSA
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• Manufacturer (Section G): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5437945
• MDR Text Key: 38228033
• Report Number: 3002769706-2016-00035
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K091024
• 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: 01/26/2016

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: 02/10/2016
• Device Catalogue Number: 43451
• Device Lot Number: 1004471680
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2016
• 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