Important Safety Alerts

Medical device manufacturer, BioMerieux, has issued field safety notices (FSN) concerning shelf-life claims and potential performance issue on strain categorization of its ETEST products.

The manufacturer has observed that the current shelf-life claims of FOAM packagings of Ceftazidime TZ256, Ciprofloxacin CI 32, Vancomycin VA 256, Benzyl Penicillin PG256, Imipenem IP32, Gentamicin GM256, Cephalotin CE256, Doripenem DOR32 and Tobramycin TM256, and BLISTER packaging of Fosfomycin FM1024 are not supported by internal testing. When used within the revised shelf-life, the products will continue to perform per its labeled performance specifications. The following issue was identified: Quality Control (QC) failure (minimum inhibitory concentrations (MICs) above the upper QC limit) for some QC strains listed in the Instructions For Use (IFU) on the affected ETEST FOAM/BLISTER packaging over after their shelf-life.

The manufacturer has also observed internally that the current shelf-life claims of the ETEST FOAM and SPB packagings of Ceftriaxone TXL32 are not supported by internal testing. As a result, there is a potential for an overestimation of the MIC values for specifically Neisseria gonorrhoeae. The following issues were identified:

• QC failure (MICs above the upper QC limit) for some QC strains listed in the IFU on the ETEST Ceftriaxone TXL32 FOAM packaging;
• QC failure (MICs above the upper QC limit) for QC strain N. gonorrhoeae ATCC 49226 listed in the IFU on the ETEST Ceftriaxone TXL32 SPB packaging after 12 months of shelf-life;
• For Streptococcus pneumoniae meningitis strains: based on 2016 CLSI guidelines a reduced MIC value might be obtained with ETEST TXL32 (SPB and FOAM packaging) that could lead to a susceptible categorization instead of intermediate categorization (Minor Error) or resistant categorization (Very Major Error) for clinical strains as compared to broth microdulution (BMD) reference method; and
• For Streptococcus pneumoniae strains (meningitis and non-meningitis): based on 2016 EUCAST guidelines a reduced MIC value could be obtained with ETEST TXL32 SBP and FOAM packaging) leading to a susceptible categorization instead of intermediate categorization for clinical strains as compared to BMD reference method: Minor error.

As a result of the observed performance issue, there is a potential to obtain a MIC result that is higher than expected. This type of error would be detectable during QC testing as an out of range MIC result would be obtained. Patient results may be elevated resulting in a false resistant result. For the ETEST TXL32 products, patient results may be elevated resulting in a false non-susceptible or a false resistant result.

According to the manufacturer, no increase of the complaint trend was observed for the affected products, but the manufacturer is taking the precaution of revising the shelf-life claims. The affected users are requested to take the actions according to the FSNs, while the replacement of the products is on-going.

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 9 January 2017