MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST® ERTAPENEM ETP 32 WW B30

Catalog Number 531600

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a false susceptible ertapenem result for an external quality control sample (nequas 3419) in association with etest® ertapenem etp 32 ww b30.The customer reported that the result of the etest® was sensitive (mic 0.5) several times.The expected result was intermediate or resistant and the customer stated that disk diffusion gave the correct result.A biomerieux investigation will be initiated.

Manufacturer Narrative

Biomérieux conducted an internal investigation: this investigation was initiated due to a discrepancy between etest® etp 32 (ertapenem) reference 531600 blister, result of susceptible(s) obtained by the customer and the expected result by the neqas survey resistant(r/i ).The strain is an enterobacter cloacae complex neqas # (b)(4).During identification testing, testing confirmed result of enterobacter cloacae on vitek® 2 gn card.Clsi 2017 breakpoints enterobacteriaceae -ertapenem [ s less than or equal to 0.5 - 1 - greater than or equal to 2 r ].Eucast 2017 breakpoints enterobacteriaceae -ertapenem [ s less than or equal to 0.5 - > 1 r ].· reference method used for etest® development: agar dilution (ad) : etp mic = 0.5 mg/l : s.· reference method recommended by neqas : broth microdilution (bmd) : etp mic = 1 mg/l : i.· mechanism of resistance detection: pcr imp, oxa48 like, kpc, ndm and vim negative (essay msast-465).·a reproducibility study was performed on etest®.All qc strains were conform (pseudomonas aeruginosa atcc 27853, escherichia coli atcc 25922, staphylococcus aureus atcc 29213, enterococcus faecalis atcc 29212, bacteroides fragilis atcc 25285, streptococcus pneumoniae atcc 49619, haemophilus influenzae atcc 49766) and the neqas strain gave mic equal to 0.5 mg/l s.Biomérieux reproduced the customer results of susceptible (s).Etest® etp (mic 0.5 ¿g/ml s) is an essential agreement with the reference mic 0.5 mg/l obtained with agar dilution (method used for the development of etest etp strip ) , without category error.Etest® etp strip performed as intended, and no further action is required.The broth microdilution which is the method used by neqas, was also performed.It gave an etp mic equal to 1 mg/l i.This result is in the middle of the clsi breakpoints, so within 1 doubling dilution the category can be s or r.

• Brand Name: ETEST® ERTAPENEM ETP 32 WW B30
• Type of Device: ETEST® ERTAPENEM ETP 32 WW B30
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6354960
• MDR Text Key: 68351120
• Report Number: 3002769706-2017-00036
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K020748
• 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: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 531600
• Device Lot Number: 1003530750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1