FDA Adverse Event
Injury
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 6964950
·
Received October 20, 2017
Report
- Report Number
- 3007981285-2017-30467
- Event Type
- Injury
- Date Received
- October 20, 2017
- Date of Event
- September 27, 2017
- Report Date
- October 20, 2017
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, 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 THE CUSTOMER EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS FOR THE PAST FEW DAYS RANGING FROM 250-425 (MG/DL). REPORTEDLY, THE CUSTOMER BELIEVED THE PUMP WAS NOT DELIVERING INSULIN. CORRECTION BOLUS WERE DELIVERED TO ADDRESS BG LEVEL. REPORTEDLY, THE CUSTOMER TOOK TYLENOL ON (B)(6) 2017. THE CUSTOMER DECLINED TO PERFORM TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 745252 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |