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Model Number 9500-27 |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 08/16/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The dexcom g5 mobile continuous glucose monitoring system user's guide states: on rare occasions, the sensor wire may break or detach from the sensor pod.If a sensor wire breaks under the skin with no portion of it visible, don't remove it.Contact your healthcare professional if you have redness, swelling, or pain at the insertion site.
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Event Description
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Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced a broken sensor wire.The sensor inserted on (b)(6) 2016.Patient reported that upon removal of the sensor pod, a part of the sensor wire was still attached to the sensor pod and another portion of the sensor wire was left in her skin.On (b)(6) 2016 the patient went to the emergency room (er) to have the sensor wire removed.At the time of contact, the patient was well.No additional event or patient information was provided.No product or data was provided for investigation.The reported event of broken sensor wire could not be confirmed.A root cause could not be determined.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Two sensor were returned for evaluation.However, it cannot be determined which sensor is the device at fault.A visual inspection was performed on the sensor (serial number (b)(4)/ lot number 5209460) and found that the wire is not broken from the sensor pod and housing puck.The customer's complaint of a broken sensor wire was not confirmed.A root cause could not be determined.A visual inspection was performed on the sensor (serial number (b)(4)/ lot number 5209460) and found that the wire is detached from the sensor pod and housing puck.The customer's complaint of a broken sensor wire was not confirmed.A root cause could not be determined.
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Search Alerts/Recalls
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