FDA: hospitals should drop glucose meter after 71 reports

A hand held blood sugar meter used in hospitals can put one patient’s result in another patient’s chart. The meter is Nova Biomedical’s StatStrip Glucose Hospital Meter. On Oct. 30 the FDA updated its recall notice. Hospitals that have another meter should stop using this one until a software update arrives.

The FDA calls it the most serious type of recall. Using it without the fix can cause serious injury or death, the agency says.

What goes wrong

A nurse scans the barcode on a patient’s wristband before a finger stick. On the affected meter, the last patient’s information can stay on the screen after that scan. If the nurse presses Accept, the glucose result goes into the wrong patient’s medical record. The same glitch can hit quality control scans.

The meter still measures blood sugar correctly. The problem is whose name the number lands under.

Nova had received 71 reports of the problem from customers, the company said in its Oct. 5 customer notice. The FDA lists one serious injury and no deaths. In that case a patient got insulin based on another patient’s glucose result. Nova learned of it on July 17, according to the company announcement the FDA posted.

The FDA lists three kinds of harm. Treatment can come too late. A patient can get treatment they do not need, such as insulin. Or a patient can get no treatment at all. Critically ill patients and infants face the most risk. Many cannot tell staff they feel the signs of low blood sugar.

Which meters

Only the newest model, which Nova calls Gen 2.0, is affected. That covers model 63685 and the multipack 66739, on every firmware version. Older StatStrip models, Gen 1.0 through Gen 1.87, are not part of the recall. These are hospital meters, not the meters people use at home.

Nova started the correction on July 24 and first wrote to customers on July 31. It sent a revised letter on Oct. 5 and has stopped shipping the Gen 2.0 meter. A software update is set to roll out in phases in November 2026.

What hospitals are told to do

Until the update, Nova and the FDA ask hospitals to:

• Turn on the “Validate Patient ID’s” setting in Nova’s NovaNet software, where the hospital’s records system shares admission data.
• Set the meters to log the nurse out after every test.
• Check the name, date of birth and other details on the screen after every scan, before pressing Accept, and again when the result appears.
• Flag or remove any result filed under the wrong patient right away, and tell the care team.

Hospitals without a backup meter can keep using the StatStrip if staff follow those steps.

What it means for you

Patients in the hospital who get finger stick blood sugar checks can ask the nurse to confirm their name on the meter before the result is saved. That matters most for anyone on insulin.

Problems can be reported to Nova at 1-800-545-6682 and to the FDA’s MedWatch program.