On (b)(6) 2017, abbott point of care (apoc) was contacted by a customer who reported observing smoke coming from analyzer sn (b)(4).The i-stat was operating with rechargeable batteries.The customer states that the analyzer did not get warm or hot to the touch.Apoc has determined that a component failure within the analyzer circuitry, may lead to the batteries becoming uncomfortably hot to touch in the area of the battery compartment when using a green non-fused battery carrier.However, the customer states that rechargeable batteries were being used.Therefore the analyzer is unlikely to become hot to touch.The product was replaced and returned for investigation.Based on the information available, there were no patient or user related injuries associated with this complaint.
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