MDA/2007/032 - Point of care blood glucose measurement systems: HemoCue

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Problem:
Potential for unreliable blood glucose readings when testing samples from pre-term neonates (less than 37 weeks’ gestation).

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Action by:

• Staff treating pre-term neonates based on the results of these devices.
• Healthcare personnel procuring, using or managing these devices.

Action:
Ensure that all relevant staff that use these devices are advised to:

• follow the manufacturer’s advice that ‘Any results with HemoCue Glucose Systems suggesting clinical intervention in the hyperglycaemic range on preterm neonates (<37 weeks) should be verified against a suitable laboratory reference method.’
• interpret any results for pre-term neonates with caution whether or not the result suggests clinical intervention
• continue to establish reference values and interventional levels for all neonatal samples as advised in the manufacturer’s instructions for use.

Distributed to:

* via CE Bulletin

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