FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 8383172
·
Received March 1, 2019
Report
- Report Number
- 3004753838-2019-022643
- Event Type
- Malfunction
- Date Received
- March 1, 2019
- Date of Event
- February 12, 2019
- Report Date
- June 28, 2019
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- UDI-DI
- 00386270000019
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PRODUCT WAS EVALUATED. THE DEVICE WAS VISUALLY INSPECTED AND FOUND THAT THERE WAS NO DAMAGE TO THE NEEDLE OR CANNULA. THE REPORTED EVENT OF A DETACHED NEEDLE WAS NOT CONFIRMED. A PROBABLE CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2019, THAT ON 02/12/2019, THERE WAS A REPORTED DETACHED NEEDLE. THE SENSOR WAS INSERTED AT THE ABDOMEN ON 02/12/2019. NO PRODUCT WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE PROBLEM AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175065 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | 9500-27 | NI | 00386270000019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |