Important Safety Alerts

Medical device manufacturer, bioMérieux, has issued a medical device safety alert concerning its Etest PIP/TAZO/CON‐4 PTC 256. [Product Reference Numbers: 412434, 412433, 521418 and 521458]

Based on a low Minimum Inhibitory Concentration (MIC) report from the field, the manufacturer initiated a complaint investigation (PR 929981) to confirm product performance and determine root cause. As a result of the investigation, the following was identified:

• Isolates (Enterbacteria strains) were tested with agar dilution and broth micro dilution reference method:
  • Using EUCAST breakpoints (MIC< or =8: Susceptible; MIC>16: Resistant), Etest PIP/TAZO showed a higher frequency of erroneous results, false susceptible results, when comparing to the referenced method (Broth-Micro Dilution).
  • Performance using CLSI breakpoints (compared to Broth Micro Dilution referenced method) was similar to EUCAST.
  • In conclusion, the data analysis demonstrates that the Etest Piperacillin/Tazobactam performance has shifted when compared to the published performance characteristics.

According to the manufacturer, the risk to patients as a result of the Etest PIP/TAZO/CON‐4 PTC 256 performance shift is the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results. This risk may lead to medical intervention for the patient because the erroneous result could negatively influence the selection of antibiotic therapy.

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

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

Posted on 27 November 2015