FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 8918534
·
Received August 21, 2019
Report
- Report Number
- 3013756811-2019-49707
- Event Type
- Malfunction
- Date Received
- August 21, 2019
- Date of Event
- July 30, 2019
- Report Date
- August 21, 2019
- Manufacturer
- DEXCOM, INC.
- Product Code
- OYC
- UDI-DI
- 00386270000019
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PER THE TANDEM USER GUIDE, ¿MAKE SURE A SENSOR GLUCOSE READING SHOWS IN THE UPPER RIGHT PORTION OF THE CGM HOME SCREEN BEFORE CALIBRATING.¿ NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WERE INTERMITTENT INACCURACIES BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) READING AND THE BLOOD GLUCOSE (BG) METER READING. REPORTEDLY, THE CGM BG READINGS WERE 120-182 MG/DL, AND THE METER BG READINGS WERE 62-283 MG/DL. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. REPORTEDLY, THE CUSTOMER PERFORMED CALIBRATIONS WHEN THERE WAS NO BG VALUE DISPLAYED ON THE CGM HOME SCREEN. A REPLACEMENT SENSOR WAS SENT TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 710214 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | DEXCOM, INC. | 9500-27 | 7254907 | 00386270000019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR |