MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST® CIPROFLOXACIN CI 32 WW S30

Catalog Number 412311

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) reported issues while quality control testing with; etestiprofloxacin ci 32 ww s30.The lot results for mh made home and mh e results were: on mh "made home" cmi= 0,094 mg/l mh-e: cmi = 0,125 mg/l range = 0,25 to 1 saline solution used = 0,85%.The customer also tested all the strips etest with cqi and etest cipro /cqi p.Aeruginosa atcc 27853 also did not conform.

Manufacturer Narrative

A customer in (b)(6) notified biomérieux of a discrepant result associated with etest® ciprofloxacin ci 32 involving failed quality control (qc) results for pseudomonas aeruginosa atcc 27853 sample.The qc results obtained by the customer were out of range low.An internal biomérieux investigation was performed with results as follows: qc tests were performed with etest® ciprofloxacin ci 32 and pseudomonas aeruginosa atcc 27853.The qc tests were performed 3 times with the customers lot.Results- qc results obtained with pseudomonas aeruginosa atcc 27853, were not conform.The customer's issue was reproduced.Qc values obtained with this strain were below the limit values of the range: 0.25 g/ml.However, no reference batch was tested in parallel.Therefore, a complementary study was performed on atcc 27853 and pseudomonas clinical strains.The pseudomonas aeruginosa atcc 27853 was tested with all the lots of etest® ciprofloxacin ci 32 foam and spb (not already expired and available on the market) on mhe and mh bd agar.Results- the (b)(4) strips have been tested on mhe agar: five (5) non-conformities were observed (mic: 0.125 g/ml) - 3.8% of non-conformed results.The (b)(4) have been tested on mhbd agar - results were conformed for all lots.On (b)(4)strips tested, with any agar used, only five (5) non-conformities (mic: 0.125 g/ml) have been detected with pseudomonas aeruginosa atcc 27853, meaning 1.9% non-conformity.In conclusion, the rate of the non-conformity on the lots in the market is 1.9% (3.8% when etest® ciprofloxacin ci 32 is used on mhe agar, 0% when using mhbd agar); therefore, within the acceptance criteria of the fda and iso standard (<=5%).An investigation was performed with a complementary kit (44 strains) of pseudomonas clinical strains with etest® ciprofloxacin ci 32 on mhe and mh bd agar.The strains tested were representative of the concentration range of etest® ciprofloxacin ci 32 and of the critical concentrations of clsi and eucast standards.Twenty- one (21) of the 44 strains had a mic value between (0.5-4mg/l) corresponding to the critical concentrations of the eucast and clsi standards.This specific selection of the strains and the precision of the antibiotic susceptibility testing method that is currently accepted (+/- 1 dilution), could lead to an increase of the minor errors (threshold effect).Then, in parallel, the qc strain p.Aeruginosa atcc 27853 was also tested.Reference methods used: agar dilution (ad) method - reference method used at the moment of the registration of the etest® ciprofloxacin ci 32 product.Roth micro-dilution (bmd) method - reference method recognized by the clsi and eucast used as a complementary method to complete the characterization level of the strains to evaluate the clinical impact of potential discrepancies with the agar dilution (ad) method.The results of the different studies state the following: the results obtained during the different studies on pseudomonas aeruginosa strains state that etest® ciprofloxacin ci 32 could lead to a potential specifications output for the qc p.Aeruginosa atcc 27853 strain (mic: 0.125 g/ml lowest value for an expected range between mic: 0.25-1 /ml) for less than 5% of the strips tested (accepted rate for the fda and iso) but without any impact on product performance; therefore, with no patient risk based on this study.In conclusion of the review of this issue, no additional actions deemed necessary in the field.

• Brand Name: ETEST® CIPROFLOXACIN CI 32 WW S30
• Type of Device: ETEST® CIPROFLOXACIN CI 32 WW S30
• 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: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5490157
• MDR Text Key: 40030404
• Report Number: 3002769706-2016-00047
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K981138
• 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: 02/25/2016

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: 11/29/2020
• Device Catalogue Number: 412311
• Device Lot Number: 1004488570
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2016
• Initial Date FDA Received: 03/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2015
• 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