FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 7525606
·
Received May 18, 2018
Report
- Report Number
- 3013756811-2018-16570
- Event Type
- Malfunction
- Date Received
- May 18, 2018
- Date of Event
- April 24, 2018
- Report Date
- May 18, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS MULTIPLE INACCURACIES BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) READING AND THE BLOOD GLUCOSE (BG) METER READING. REPORTEDLY, THE CGM BG READING WAS 202-297 MG/DL, AND THE METER BG READING WAS 126-202 MG/DL. REPORTEDLY, THE CUSTOMER PERFORMED MULTIPLE CALIBRATIONS, AND CGM READINGS BECAME ACCURATE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 369724 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | DEXCOM, INC. | 9500-27 | 5235295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |