On (b)(6) 2019, abbott point of care (apoc) was contacted by a customer who reported that i-stat1 analyzer sn (b)(4) displayed code 66 and 86.Customer reports when the batteries were removed from the analyzer they were hot to touch.The customer also reports that when different batteries were installed in the analyzer, code 66 and 86 still persist.There was no additional information at the time of this report.The analyzer was replaced at no charge and returning for investigation.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 ((b)(4)) were being used at the time of the event.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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Apoc incident #: (b)(4).The investigation was completed on 04/24/2019.The customer reported that analyzer s/n (b)(4) generated quality check (qc) codes 66 and 86 and the rechargeable power pack was hot to touch.The conclusion of the engineering evaluation for this incident was that the customer's complaint of qc code 66 was reproduced.During the evaluation, it was determined that the thermal probe flex cable has slid out from its zif connector on the main board.The contact pads of the thermal flex cable were found to be worn, which, combined with multiple drops of the analyzer, led directly to the cable separating from the connector.The customer complaint of the rechargeable power pack becoming hot to touch could not be confirmed because the battery was not returned to flex.A rocketware search spanning six months revealed no similar incidents and no evidence of a trend.No deficiency has been identified.
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