FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 10145392
·
Received June 11, 2020
Report
- Report Number
- 3013756811-2020-61309
- Event Type
- Malfunction
- Date Received
- June 11, 2020
- Date of Event
- May 20, 2020
- Report Date
- June 11, 2020
- Manufacturer
- DEXCOM, INC.
- Product Code
- OYC
- UDI-DI
- 00386270000019
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SE
- 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 37, 45, 63 MG/DL, AND THE METER BG READING WAS 102, 122, 166 MG/DL. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT SENSOR WAS SENT TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607621 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | DEXCOM, INC. | 9500-27 | 5267489 | 00386270000019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |