FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7891629
·
Received September 19, 2018
Report
- Report Number
- 3004753838-2018-110425
- Event Type
- Malfunction
- Date Received
- September 19, 2018
- Date of Event
- September 10, 2018
- Report Date
- September 10, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- UDI-DI
- 00386270000019
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A NEEDLE RETRACTION ISSUE OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2018. 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.
Description of Event or Problem · 1
SUBSEQUENT TO THE INITIAL MDR, UPON FURTHER REVIEW OF THE COMPLAINT RECORD, IT WAS DETERMINED THAT AN AUTO-APPLICATOR NEEDLE RETRACTION ISSUE DID NOT OCCUR. THEREFORE, THIS IS A NON-REPORTABLE COMPLAINT. PLEASE DISREGARD THE INFORMATION PROVIDED IN MFR 3004753838-2018-110425.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 733367 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | 9500-27 | NI | 00386270000019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR |