MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID® MRSA 100 PLT

Catalog Number 43459

Device Problems False Positive Result (1227); 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

A customer from (b)(6) reported receiving (b)(6) results when using chromid (b)(6) plates (ref.43459 lot, 1004112990).Additional subcultures were performed using plates from the same lot and with plates from a different lot (lot number not known).They all gave (b)(6) results.Testing results were confirmed using pcr.Customer confirmed no treatment was started and there was no impact on patients.

Manufacturer Narrative

This report was initially submitted following notification that a customer in (b)(6) reported a (b)(6) in association with the chromid tm mrsa agar.Internal investigation was conducted.Retention samples for this chromid mrsa batch were tested; results obtained were in accordance with product specifications.In addition, a thermal shock process (validated during stability testing) was performed on various batches within various timeframes of the shelf-life.Just after manufacturing (1004248040 and 1004270840) after 6 weeks manufacturing (middle expiration: 1004184040 and 1004158090) at expiration date (1004142170 and 1004123930) in all cases the selectivity after performing thermal shock was in conformance with specifications for the sample strains used during stability testing ((b)(6)).The chromid mrsa product is performing as intended.

• Brand Name: CHROMID® MRSA 100 PLT
• Type of Device: CHROMID® MRSA 100 PLT
• 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: 5108445
• MDR Text Key: 26943620
• Report Number: 3002769706-2015-00104
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 09/04/2015

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: No Information
• Device Expiration Date: 09/11/2015
• Device Catalogue Number: 43459
• Device Lot Number: 1004112990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1