On (b)(6) 2019, abbott point of care (apoc) was contacted by a customer who reported that i-stat1 analyzer sn (b)(4) would not activate.The customer reports that customer is using rechargeable batteries and disposable 9 volt lithium batteries.The analyzer was replaced at no charge.The analyzer was returned for failure analysis and on 05/15/2019 it was determined that the cause for the analyzer not activating was due to component failure, c4 capacitor.On 05/15/2019 the customer stated that they are using lithium batteries with a green battery carrier.Apoc technical support emailed the customer and advised to dispose of the green 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.Refer to apoc product action apoc30aug2010: in september 2010, apoc began communicating information concerning i-stat1 handheld disposable batteries that have the potential to overheat due to a circuitry failure.This failure can cause the handheld to become uncomfortably hot to touch in the area of the battery compartment.There have been no reports of injury associated with overheated i-stat1 handheld batteries.When using disposable batteries with the i-stat1 handheld they must be inserted into a battery carrier before being inserted in the i-stat1.Apoc has developed a new battery carrier for i-stat1 handhelds featuring a fuse that provides additional protection against overheating when using disposable batteries.Recently, all new and repaired i-stat1 handhelds have begun being shipped with the fused battery carrier.These fused battery carriers are distinguished by a red printed circuit board on the topside of the "new battery carrier" which is replacing the previous green circuit board of the "old battery carrier".As part of the product action the customer received six replacement battery carriers.The customer was re-advised of apoc30aug2010 and instructed to discard all green non-fused battery carriers on site.There were no patient or user related injuries associated with this complaint.At this time of this report it had not been confirmed if the green carrier was used during the event.Failure analysis is complete, and therefore an investigation is not required.
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