Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, a missing sensor wire occurred.The sensor was inserted into the abdomen on (b)(6) 2017.No medical intervention was reported.Additional event or patient information is not available.No product was provided for evaluation.The reported event could not be confirmed.A root cause could not be determined.
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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.The root cause could not be determined.
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