FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 6976934
·
Received October 25, 2017
Report
- Report Number
- 3007981285-2017-31897
- Event Type
- Malfunction
- Date Received
- October 25, 2017
- Date of Event
- October 2, 2017
- Report Date
- October 25, 2017
- Manufacturer
- DEXCOM, INC.
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
CORRECTED DATA: PMA/510(K.
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 THE CUSTOMER RECEIVED A "REPLACE TRANSMITTER" ALERT, AND THE TRANSMITTER LOSS CONNECTION TO THE PUMP. REPORTEDLY, THE TRANSMITTER HAD BEEN IN USE LESS THAN 3 MONTHS. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 756127 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | DEXCOM, INC. | 9438-06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |