Freestyle Libre 3 Plus sensor manufacturing issue

Te Whatu Ora Health New Zealand has confirmed a national incident response is underway in relation to a manufacturing error affecting Freestyle Libre 3 Plus sensors, following reports of severe adverse events, including ICU admissions with diabetic ketoacidosis (DKA).

The manufacturing error causes affected sensors to display falsely low glucose readings. For people using Ypso insulin pumps with the CamAPS system, this can result in reduced insulin delivery, leading to very high blood glucose and ketone levels, even when sensor readings appear low.

Despite a product recall in late November last year, some impacted sensors may still be in circulation, including sensors that were likely dispatched after the recall. Nationally, not all users appear to have received or understood earlier notifications about the issue.

In response, Whakarongorau and Healthline are contacting approximately 1,800 Freestyle Libre 3 Plus users across Aotearoa New Zealand to ensure they are aware of the issue, understand how to check whether their sensors are impacted, and know when to confirm readings with finger-prick blood glucose testing.

The manufacturing error has now been fixed, and the following sensors are not affected.

• Freestyle Libre 2 Plus

• Dexcom G6

• Dexcom G7

• Dexcom ONE+

However, replacement sensors can take several days to arrive, and practices may see an increase in patient contact for:

• advice about potentially inaccurate sensor readings

• prescriptions for replacement sensors

• blood glucose or ketone test strips and meters.

Practices are encouraged to reinforce the importance of checking finger-prick blood glucose levels when sensor readings do not match symptoms, and checking ketone levels when unwell, as early confirmation has been shown to prevent harm.

Practices and services are also reminded to report any severe adverse events through local incident management systems, to support national monitoring and response efforts.

Awareness and early action remain key to preventing further harm, and practices play an important role in supporting patients during the ongoing national response. 

Patients using Freestyle Libre 3 or Freestyle Libre 3 Plus sensors are still advised to check all sensors currently at home using Abbott’s online checking process, as impacted sensors may still be in circulation despite the recall and national response. Any sensors identified as impacted should not be used and are eligible for free replacement through Abbott Customer Service. If helpful, view the Waikato Diabetes Team instructions 'How to check if a sensor is affected' (PDF).