MAUDE Adverse Event Report: BIOMERIEUX SA ETEST ® CEFEPIME PM 256 US; ETEST® CEFEPIME PM 256 US

Catalog Number 505058

Device Problem Low Readings (2460)

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer reported quality control results are out of range when using etest cefepime pm strips, ref.505058, lot 1003222380.Customer has conducted 3 quality control test with, e.Coli 25922, staphylococcus aureus 29213 and pseudomonas aeruginosa 27853 in duplicate using new strips.One out of two strips for e.Coli and staphylococcus aureus/carbapenemase-producing enterobacteriaceae were out of range.Both strips for pseudomonas aeruginosa were in range.Additional testing has been performed but results are consistently high.

Manufacturer Narrative

Biomérieux internal investigation was conducted.The customer lots of etest cefepime were tested with six (6) internal atcc tm strains.Atcc 27853 tm pseudomonas aeruginosa (range 1-4 ¿g/ml) - results obtained: 1.5¿g/ml (passed) atcc 29212 tm enterococcus faecalis (range 6-64 ¿g/ml) - results obtained: 12 or 16 ¿g/ml (passed) atcc 49247 tm haemophilus influenzae (range 0.5-2 ¿g/ml) - results obtained: 1 or 1.5 ¿g/ml (passed) atcc 49619 tm streptococcus pneumoniae (range 0.064-0.25 ¿g/ml) - results obtained: 0.125 ¿g/ml (passed) atcc 29213 tm staphylococcus aureus (range 1-4 ¿g/ml) - results obtained: 3 ¿g/ml (passed) the investigation, following the ifu recommendations, did not reproduce the customer result (6 ¿g/ml / result out of range).Atcc 25922 tm escherichia coli (range 0.016- 0.125 ¿g/ml) - results obtained: 0.047 or 0.064 ¿g/ml (passed).The investigation, following the ifu recommendations, did not reproduce the customer result (0.064 or 0.125 ¿g/ml).The investigation concluded the etest cefepime product is performing in accordance with specifications.Furthermore, follow-up with the customer indicates the etest cefepime is now passing qc after incorporating a different growth media with the proper agar characteristics.

• Brand Name: ETEST ® CEFEPIME PM 256 US
• Type of Device: ETEST® CEFEPIME PM 256 US
• 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: 5103925
• MDR Text Key: 26756450
• Report Number: 3002769706-2015-00088
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2016
• Device Catalogue Number: 505058
• Device Lot Number: 1003222380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1