FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 9090700
·
Received September 19, 2019
Report
- Report Number
- 3013756811-2019-60186
- Event Type
- Malfunction
- Date Received
- September 19, 2019
- Date of Event
- August 30, 2019
- Report Date
- September 19, 2019
- Manufacturer
- DEXCOM, INC.
- Product Code
- OYC
- UDI-DI
- 00386270000019
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) READING AND THE BLOOD GLUCOSE (BG) METER READING. REPORTEDLY, THE CGM BG READING WAS BELOW 50 MG/DL, AND THE METER BG READING RANGED IN 300S MG/DL. CUSTOMER TREATED INACCURATE BG LEVEL OF 50 MG/DL, AND SUBSEQUENTLY CUSTOMER¿S BG ELEVATED TO 300 MG/DL RANGE. CUSTOMER ADDRESSED BG LEVEL WITH A BOLUS. AT THE TIME OF THE REPORT WITH TANDEM TECHNICAL SUPPORT CUSTOMER¿S BG LEVEL WAS 256 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 884436 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | DEXCOM, INC. | 9500-27 | 00386270000019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |