The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning Viterion V100 and V500 telehealth monitors manufactured by Viterion TeleHealthcare.
According to Viterion, the affected models V100 and V500 do not accept out-of-measuring-range results, i.e. results marked "HI" or "LO" from certain blood glucose meters. The affected meters are Bayer's Contour and Roche's Accu-Chek Advantage 03 and 04 meters. This out-of-measuring-range data is not being sent from the patients' telehealth monitors to the clinician application software (EUNET), and hence the healthcare professionals are not able to review the out-of-measuring-range patient blood glucose data.
Moreover, for those patients with diabetes who are instructed by their healthcare professional to enter blood sugar results manually on these monitors, only results between 1.1 and 33.3 mmol/L may be entered. Results outside of the meter's measurable range cannot be manually entered on these Viterion monitors.
Viterion advises the affected patients, who see HI or LO displayed on the blood glucose meter, to contact their healthcare professional immediately. Besides, healthcare professionals should watch out for any 'skipped' or 'timeout' values seen in patient reports.
According to the local supplier, the affected products have not been distributed in Hong Kong.
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/ fieldsafetynotices/CON213146
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 December 2012