DEXCOM CLARITY SOFTWARE WEB BASED LBL013732, REV 11

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-25 for DEXCOM CLARITY SOFTWARE WEB BASED LBL013732, REV 11 manufactured by Dexcom, Inc..

Event Text Entries

[112550430] This pt wears an insulin pump and a continuous glucose monitor (cgm) which she wears continuously. Her cgm is dexcom g6 system which she downloads to clarity software program both by direct cable connection and via dexcom mobile app via bluetooth to her cell phone. She has given permission to share her uploaded data by accepting a sharing invitation from my clinic. Per the user guide, data uploaded by the patient from both dexcom receiver and dexcom mobile app will be available le for viewing at the clinic. On (b)(6) the patient contacted the office via email for assistance with titrating her insulin and requested that i view her information on clinic version of the clarity software. The data shown on her account was notable for significant elevation overnight. As a result, i emailed the patient to change her insulin dose in the late evening to early morning - increasing her dosage by 30 percent. On (b)(6), pt emaiiled questioning the increase. She stated her late event and overnight bs were not that elevated. In fact there was no elevations on (b)(6). At that point she took a screen shot of her clarity software with the most recent 3 days. Her view of the clarity account differed from the clinic version. On (b)(6) at 12:03 am, her bs was approximately 160 mg, the clinic version of the clarity identified that the bs was close to 240 mg/dl, from 1 am to 12:30 pm, her data was under 180 mg. However the clinic clarity report showed that the bsa was not under 180 until 4am. On her version, at 2pm her bs rose over 180mg and was 280mg at 3:30 pm. On the clinic view of her data, her bs at 3:30 pm was about 100mg. Pt has data that is available for (b)(6) but nothing is available on the clinic data.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5078039
MDR Report Key7637720
Date Received2018-06-25
Date of Report2018-06-20
Date of Event2018-06-18
Date Added to Maude2018-06-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDEXCOM CLARITY SOFTWARE WEB BASED
Generic NameCONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE
Product CodePHV
Date Received2018-06-25
Model NumberNA
Catalog NumberLBL013732, REV 11
Lot NumberNA
ID NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerDEXCOM, INC.
Manufacturer Address6340 SEQUENCE DRIVE SAN DIEGO CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2018-06-25

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