Dexcom was made aware on (b)(4) 2017 that on (b)(6) 2017 the sensor wire was missing.Additionally, the patient stated that the sensor wire issue included pain and discomfort at the insertion site.The sensor was inserted at the thigh on (b)(6) 2017.Reportedly, the patient removed the transmitter prior to removing the sensor pod.No medical intervention was reported.No additional event or patient information is available.No product or data were provided for evaluation.The reported missing sensor wire could not be confirmed.A root cause could not be determined.Labeling indicates: sensor placement and insertion is not approved for sites other than the belly (abdomen).Labeling indicates: do not remove the transmitter while the sensor pod is still attached to the body.
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The complaint device was returned for evaluation.The complaint indicates that the patient reported a missing sensor wire.Based on visual inspection, testing concluded that the sensor wire with (b)(4) is missing from the sensor pod and seal carrier.The problem is confirmed because the sensor wire with (b)(4) was missing from the sensor pod and seal carrier.Because the sensor wire is missing, it is considered detached.The root cause could not be determined.
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