Important Safety Alerts

Medical device manufacturer, BioMerieux, has issued field safety notices (FSN) concerning its ETEST XM256 (Cefuroxime) FOAM and SPB (FOAM reference numbers: 506958, 506918 and SPB reference numbers: 412304, 412305)

An analysis was performed on the Essential Agreement rate reflecting the minimum inhibitory concentrations (MIC) result obtained by the product for a significant strains kit including Enterobacteriaceae, Haemophilus and S. pneumonia Species. Then, an additional analysis was done on the clinical categorization of the strains based on CLSI guidance.

According to the manufacturer, the following have been identified:

• The investigation confirmed a potential performance issue on strains categorization for Streptococcus pneumoniae and for Enterobacteriaceae strains limited to oral cefuroxim breakpoints and based on 2016 CLSI clinical standards only:
  • For Streptococcus pneumoniae on ETESTR XM256 (Cefuroxime) FOAM and SPB that could lead to minor error on clinical strains
    • False Susceptible result instead of Intermediate results with BMD (Broth Micro Dilution) reference method
    • False Intermediate result instead of Resistant results with BMD reference method
  • For Enterobacteriaceae on ETESTR XM256 (Cefuroxime) FOAM and SPB that could lead to minor error on clinical strains:
    • False Susceptible result instead of Intermediate results with AD (Agar Dilution) reference method
    • False Intermediate result instead of Resistant results with AD reference method.
• Products perform within the specification when using the 2016 EUCAST guidelines.

As the result of the referenced issue, the potential hazard is to obtain Minor error (Susceptible instead of Intermediate or Intermediate instead of Resistant) on strain categorization for Streptococcus pneumoniae and for Enterobacteriaceae strains only when using the 2016 CLSI clinical breakpoints defined for cefuroxime oral forms.

The affected users are advised to follow the instructions and implement the actions as indicated in the FSN.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 25 January 2017