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 austria reported to biomérieux a false susceptible ertapenem result for an enterobacter cloacae complex, external quality control sample ((b)(4)), in association with etest® ertapenem etp 32 ww b30.The customer reported the etest® result was out of range low (mic 0.5 ug/ml) and the expected result was resistant (mic > = 2 ug/ml).The sample was tested with vitek® 2 and the result was mic 2 ug/ml.Testing with the disc method produced a result of 20 mm.As the issue occurred during external quality control testing, there was no patient involvement.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from austria reported to biomérieux a false susceptible ertapenem result for an enterobacter cloacae complex, external quality control sample ((b)(4)), in association with etest® ertapenem etp 32 ww.An investigation was performed.The sample identification was confirmed as enterobacter cloacae with the vitek® 2 gn card.Susceptibility testing included the use of: clsi 2017 breakpoints enterobacteriaceae -ertapenem [ s /= 2 r ].Eucast 2017 breakpoints enterobacteriaceae -ertapenem [ s 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 with the etest customer lot and a reference lot, and the customer result (s) was reproduced.All qc strains (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) were conforming and the neqas strain gave mic equal to 0.5 mg/l s.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.In conclusion , the customer's susceptible result with etest etp was duplicated.The etest etp (mic 0.5 ;g/ml s) is in 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.The etest etp strip performed as intended, and no further action is required.

• 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: 6443992
• MDR Text Key: 71222232
• Report Number: 3002769706-2017-00057
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Catalogue Number: 531600
• Device Lot Number: 1003569060
• Other Device ID Number: 03573026249380
• 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: 11/12/2014
• 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