Published: 6 June 2013

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Monitoring Blood Glucose

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Prescriber Update 34(2):20
June 2013

Medsafe has been notified of observed variations between readings provided by the CareSens meter and other blood glucose meters.

Differences in readings can be a matter of concern for patients and clinicians, so it is important to differentiate between acceptable variation in meter readings and those that may have clinical consequences.

From March 2013, the CareSens range of blood glucose meters and testing strips became the only blood glucose testing devices funded by PHARMAC. These meters will be new to most patients and include:

1. CareSens II: manual coding (requires entry of a test strip code), 250 test memory, 14 day averaging
2. CareSens N: no coding, 250 test memory, 14 day averaging
3. CareSens N POP: no coding, 500 test memory, 1/7/14/30 90 day averaging

The manufacturer states that the meters meet the international standard and have been tested for acceptability in New Zealand (Christchurch Diabetes Centre).

It is possible that two blood glucose meters meeting the same standard will give different results. This does not mean that either of the meters is wrong. The international standard for blood glucose meters requires that they are accurate to within plus or minus 20% of a laboratory test result, 95% of the time.

Medsafe acknowledges that even a small difference in readings may worry diabetics. Consumer information and support for diabetics changing to the CareSens blood glucose meters is available from the CareSens website (www.caresens.co.nz/page/faq.aspx).

Information on how to report a medical device issue can be found on the Medsafe website (www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp).

If you wish to report a potential issue with a meter to Medsafe, please include:

• details of the meters (models and serial number)
• the lot numbers of the testing strips
• examples of differences in readings between the two meters using blood samples drawn and tested at the same time
• examples of any unusual variability between serial readings taken on the meter • any information on clinical issues with glucose meters.