Dexcom was made aware on 08/31/2016, that on (b)(6) 2016, the patient experienced a detached sensor wire.The sensor was inserted into the arm on (b)(6) 2016.Patient's mother reported that upon sensor pod removal no sensor wire was visible from the underside of the sensor pod.The sensor wire was not visible through the skin, and the insertion site was describe as having palpable bump.Patient's mother reported that the sensor was functioning as normal for 9 days then suddenly failed.Dexcom representative advised mother that the sensor should not be worn for more than 7 days.Patient's mother reported that the patient was in urgent care being seen about the missing sensor wire.At the time of contact patient is good.No additional patient or event information was provided.The sensor was inserted into the arm.Labeling indicates: do not insert the sensor in sites other than the belly (abdomen) or upper buttocks.Use in other sites might cause sensor glucose readings to be inaccurate and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
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A sensor (serial number (b)(4)/ lot 5209805) was returned for evaluation; however, it cannot be determined if this is the device at fault.A visual inspection was performed and found that the wire is missing from the sensor pod and housing puck.Due to the missing sensor wire, the sensor wire is considered detached.The customer's complaint of a missing sensor wire was confirmed.A root cause could not be determined.
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