FDA Adverse Event
Malfunction
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 2802143
·
Received October 23, 2012
Report
- Report Number
- 3004753838-2012-00292
- Event Type
- Malfunction
- Date Received
- October 23, 2012
- Date of Event
- September 30, 2012
- Report Date
- September 30, 2012
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P050012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEXCOM, INC. AND FDA AGREED DURING A FACILITY INSPECTION THAT ANY POSSIBLE BROKEN SENSOR WIRE WAS A REPORTABLE EVENT, EVEN IN THE ABSENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT ON THE SAME DAY, HER FIRST-EVER SENSOR FELL OFF AFTER ABOUT 3 DAYS OF WEAR. A SMALL PORTION OF THE WIRE APPEARED TO BE MISSING FROM THE SENSOR. PATIENT WAS ABLE TO REMOVE A SMALL PIECE OF WIRE FROM UNDER HER SKIN AT THE POINT OF INSERTION. AT THE TIME OF HER CALL TO TECHNICAL SUPPORT, THE PATIENT REPORTS A SMALL RED BUMP AT INSERTION SITE, BUT NO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9500-03 | 5042473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other |