MAUDE Adverse Event Report: BIOMERIEUX SA CHROMID (TM) MRSA 20 PLT

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  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

On (b)(6) 2015 a customer in (b)(6), reported a false resistant result when using product chromid (tm).The patient's nasal specimen was incubated for 24 hours, there was no enrichment phase.It was confirmed the device was used prior to expiration date, plates inoculated on (b)(6) and read on (b)(6) 2015.Identification was later performed using vitek.Customer confirmed the incorrect result was not provided to the treating physician, no patient harmed but there was a 24 hour delay in providing correct results.

Manufacturer Narrative

Biomérieux internal investigation was conducted.Evaluation of the manufacturing qc batch records indicates no discrepancies were detected during the manufacturing, and the chromid tm mrsa agar performed in accordance with specifications as indicated in the quality certificate.Investigation testing included: vitek 2 gp id identified staphylococcus aureus.Two (2) random lots of chromid mrsa agar (customer lot was expired) using the customer submitted strain, staphylococcus aureus atcc 43300 mrsa, and staphylococcus aureus atcc 29213 mssa.There was no growth (b)(6) after 48 hours of incubation with both lots of chromid mrsa.Growth of both atcc strains was as expected for each strain and (b)(6) type.The investigation did not reproduce the customer (b)(6).This investigation concluded that performance of chromid mrsa agar reference 43451 lot 1004254660 is within specification and in accordance with the data indicated in the package insert.

• Brand Name: CHROMID (TM) MRSA 20 PLT
• Type of Device: CHROMID (TM) MRSA 20 PLT
• 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: 5262056
• MDR Text Key: 32582020
• Report Number: 3002769706-2015-00157
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 12/01/2015

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: 11/13/2015
• Device Catalogue Number: 43451
• Device Lot Number: 1004254660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1