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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9500-35
Device Problem Imprecision (1307)
Patient Problems Weakness (2145); Dizziness (2194)
Event Date 10/28/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced inaccuracies between the continuous glucose monitor (cgm) and blood glucose (bg) meter. The sensor was inserted into the abdomen on (b)(6) 2019. On (b)(6) 2019, the patient's cgm value was 303 mg/dl but her bg value was 150 mg/dl. The time of the cgm and bg values were not provided or if the values were pre- or post-treatment. The patient was transported to the hospital by emergency medical services (ems) and was admitted overnight. She reported dizziness and weakness. It is not known if the patient experienced a hypo or hyperglycemic event. At the time of contact, that patient was in stable condition and discharged from the hospital as of (b)(6) 2019. No data or product was provided for investigation. Confirmation of the allegation was undetermined. The probable cause could not be determined. The reported glucose values fall within the c zone of the parkes error grid. No additional patient or event information is available.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
ying chen
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key9335892
MDR Text Key166814299
Report Number3004753838-2019-089257
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
Report Date 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/22/2020
Device Model Number9500-35
Device Catalogue NumberSTS-GL-006
Device Lot Number7249786
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 Received10/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/18/2019 Patient Sequence Number: 1
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