FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 8009719
·
Received October 26, 2018
Report
- Report Number
- 3013756811-2018-36772
- Event Type
- Malfunction
- Date Received
- October 26, 2018
- Date of Event
- October 3, 2018
- Report Date
- October 26, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- OYC
- UDI-DI
- 003862700000195229727
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 INTERMITTENT INACCURACIES BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) READING AND THE BLOOD GLUCOSE (BG) METER READING. REPORTEDLY, THE CGM BG READING WAS 40-244MG/DL, AND THE METER BG READING WAS 133-177 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 |
|---|---|---|---|---|---|---|---|
| 850128 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | DEXCOM, INC. | 9500-27 | 5229727 | 003862700000195229727 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |