On (b)(6) 2015, abbott point of care (apoc) was contacted by a customer who reported that analyzer sn (b)(4) became hot to touch and does not hold a charge.The customer states that it has happened on multiple downloaders.Customer inserted 9v lithium batteries and the analyzer does not activate.The customer states the analyzer was operating with rechargeable and batteries with a red (fused) battery carrier.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 and also a red fused battery carrier was being used.Therefore the analyzer is unlikely to become hot to touch.The product was replaced and returning for investigation.Based on the information available, there were no patient or user related injuries associated with this complaint.
|