FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3679310
·
Received March 14, 2014
Report
- Report Number
- 3004753838-2014-12803
- Event Type
- Malfunction
- Date Received
- March 14, 2014
- Date of Event
- October 17, 2013
- Report Date
- October 17, 2013
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SUBSEQUENT TO THE FIRST FOLLOW-UP FOR THIS MDR REPORT NUMBER 3004753838-2014-12803, IT WAS NOTICED THAT THE INCORRECT MDR REPORT NUMBER HAD BEEN ENTERED ON IT. PLEASE DISREGARD THE FOLLOW-UP REPORTS WITH 3004753838-2014-12803. THE INFORMATION CONTAINED WITHIN THAT REPORT WAS SUBMITTED IN A FOLLOW-UP REPORT FOR 3004753838-2015-12803, SR-202377.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
CONSUMER CONTACTED DEXCOM TO REPORT THE SENSOR GAVE INACCURATE BLOOD GLUCOSE READINGS. THE CONSUMER DID NOT REPORT ANY MEDICAL INTERVENTION OR INJURIES.
Description of Event or Problem · 1
SUBSEQUENT TO THE INITIAL MDR, THE DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT THAT THE PATIENT'S MOTHER REPORTED THE INACCURATE VALUES. NO FURTHER EVENT OR PATIENT INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153509 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9500-25 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |