DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM; SENSOR, GLUCOSE, INVASIVE
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Model Number 9500-35 |
Device Problem
Imprecision (1307)
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Patient Problem
Hyperglycemia (1905)
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Event Date 12/17/2019 |
Event Type
Injury
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Manufacturer Narrative
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No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that there was an inaccuracy between the continuous glucose monitor (cgm) reading and the blood glucose (bg) meter reading.Reportedly, the cgm bg reading was 158-159 mg/dl, and the meter bg reading was 540-550 mg/dl.A replacement sensor was sent to the customer.Customer reported that the elevated blood glucose level was not addressed because of the inaccurate cgm readings.Customer needed to be carried to the restroom by customer's mother.Customer delivered a bolus to address the elevated bg level.
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Search Alerts/Recalls
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