On (b)(6) 2017, abbott point of care (apoc) was contacted by a customer who reported that analyzer sn (b)(4) would not activate.The analyzer was replaced at no charge and returned for routine failure analysis.The analyzer was received on 10/16/2017 and on 10/24/2017 during failure analysis it was noted that capacitor c13 on main pcba was burnt.The customer returned the analyzer with green non-fused battery carrier.The customer was never issued battery carrier letter # apoc30aug2010 - september 2011.It is unknown how the customer obtained a green non-fused battery carrier since the customer has only been an i-stat user since 2016.The analyzer was shipped to the customer on (b)(6) 2016 with a red fused battery carrier.The customer searched the facility and stated that they only have red-fused battery carriers on site as of (b)(6) 2017.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 does state that 9 volt batteries were being used.Therefore the analyzer is likely to become hot to touch.Based on the information available, there were no patient or user related injuries associated with this complaint.
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