FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN
MDR report key: 6095794
·
Received November 11, 2016
Report
- Report Number
- 3004753838-2016-54312
- Event Type
- Malfunction
- Date Received
- November 11, 2016
- Date of Event
- October 20, 2016
- Report Date
- October 20, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Removal / Correction Number
- 3004753838-02/29/16-001C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(6) 2016 THAT ON (B)(6) 2016 THE RECEIVER HAD INTERMITTENT AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 746275 | UNKNOWN | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR |