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Saudi Food and Drug Authority warns from using OneTouch® Verio® Pro+ blood glucose meters (Hospital and clinics use)

2013-05-23

​Saudi Food and Drug Authority represented by the medical devices sector  would like to warn all  healthcare practitioners from using OneTouch® Verio® Pro+ blood glucose meters (hospital and clinics use), manufactured by Lifescan Johnson & Johnson company due to incorrect test results stored in results log at extremely high blood glucose levels  above 1023 mg/dL (56.83 mmol/l).
SFDA has become aware through Lifescan Johnson & Johnson that recalling and replacing all OneTouch Verio Pro+ blood glucose meters because:
1- The meters are not working as expected when measuring a blood glucose level above 1023 mg/dL (56.83 mmol/l)
2- The meter will display a correct high value warning, but will record incorrect low glucose results in the memory at extremely high blood glucose levels above 1023 mg/dL (56.83 mmol/l)
3- The hazard associated with this issue is inaccurately low blood glucose results when using the meter memory to retrieve blood glucose results.
SFDA assures the implementation of corrective actions for OneTouch® Verio® Pro+ blood glucose meters with the manufacturer authorized representative.

Saudi Food and Drug Authority recommends all healthcare practitioners to adhere to the following :
- You can continue to use your current OneTouch® Verio® Pro+ Meter because the test results and warning messages displayed at the time of the test are unaffected by this issue, until you receive the replacement . However, it is important that you do not rely on test results stored in the results log to make patient treatment decisions as they may be inaccurate.
- Call Lifescan customer services at 8002440266 to receive a replacement meter at no charge.
- Inform the Saudi Food and Drug Authority if you have affected products at your institution through NCMDR website:
- Distribute and disseminate of information contained in this warning to all concerned.

Saudi Food and Drug Authority encourages all  to report any adverse event associated with medical devices through the National Center for Medical Devices Reporting :
 

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