The MHRA has issued a Medical Device Alert (MDA) in relation to StatStrip Glucose blood glucose meters manufactured by Nova Biomedical. These meters are for professional use only and the action is for healthcare professionals who use the devices.

The MHRA received an incident report in which samples from a renal transplant patient gave recurrent sample flow error codes on the StatStrip Glucose meter, masking the patient’s abnormal glucose level.

The meter may generate consecutive error codes for multiple samples from the same patient, which may mask abnormal glucose levels.

The MHRA has advised that if the meter gives two or more error codes for the same patient, an alternative point of care device or a laboratory based method should be used.

Deadline dates for this alert:
Action underway: 26 May 2011
Action complete: 09 June 2011