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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. CONTINUOUS GLUCOSE MONITOR

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DEXCOM, INC. CONTINUOUS GLUCOSE MONITOR Back to Search Results
Catalog Number STS-GS-003
Device Problem Imprecision (1307)
Patient Problems Hypoglycemia (1912); Dizziness (2194); Sweating (2444)
Event Date 10/31/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia.
 
Event Description
It was reported that an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter occurred. The sensor was inserted into the abdomen on (b)(6) 2020. The patient was at home and experienced sweating and dizziness during the night. The cgm at the time was displaying 400 mg/dl. The bg reading was taken twice, and the value was under 40 mg/dl. The patient¿s daughter removed the sensor and called the emergency doctor. Glucagon was given at the patient¿s home by the emergency doctor. The patient was then taken to the hospital for standard checks (reportedly based on the patient being elderly). She went home with her husband and daughter after a short period of time. At the time of the report she was at home and in good condition. No data was provided for evaluation. Confirmation of the allegation and a probable cause could not be determined. The reported glucose values fall within the e zone of the parkes error grid. No additional patient or event information is available.
 
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Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
ashley spoto
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key10878743
MDR Text Key217618190
Report Number3004753838-2020-141299
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
Report Date 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSTS-GS-003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/20/2020 Patient Sequence Number: 1
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