The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety alert on popular blood glucose meter designed for diabetics with poor vision because it does not issue an audible alert if an insufficient amount of blood has been drawn.
According to a statement from the agency, this could result in inaccurate tests if a test strip used in the machine is either under- or over-filled. An inaccurate result could lead a diabetic relying on this device to deliver an incorrect amount of insulin, either too little or too much.
The statement concerns the Clever Chek blood glucose monitoring system, a palm-sized device with an extra-large display that’s designed to help diabetics with poor vision easily read their test results. The Clever Chek device is distributed by BBI Healthcare. It is manufactured by TaiDoc Technology Corp.
MHRA is currently urging healthcare professionals and people who rely on the Clever Chek device to seek an alternative product to test their blood glucose levels. The agency has become aware of incidents in which a person using Clever Chek either under- or over-filled their strip with blood when checking their glucose. It is likely these patients received too little or too much insulin after conducting that check and repeatedly using the glucose monitor and expecting the same results could result in serious injuries and side effects. Low insulin levels that go unchecked for days or longer could result in serious injuries, like coma, or death.
The agency has issued the alert and is suggesting people find alternatives because Clever Chek “does not have a blood glucose test strip under-fill detection mechanism, nor does it provide feeback to users when sufficient blood has been applied.”
This alert from the UK regulators is being sent to any medical professionals who may use or distribute the Clever Chek device, including nursing homes, hospice care facilities, hospitals, private practice physicians, and diabetes care specialists. The Clever Chek device is designed for home use but may likely be used in a professional setting, too.