FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 9191805
·
Received October 15, 2019
Report
- Report Number
- 3013756811-2019-69887
- Event Type
- Malfunction
- Date Received
- October 15, 2019
- Date of Event
- September 25, 2019
- Report Date
- October 15, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
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 MULTIPLE, INTERMITTENT OCCLUSION ALARMS OCCURRED. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP BATTERY WAS NOT CHARGING. REPORTEDLY, THE CUSTOMER USED AN ALTERNATE USB CABLE TO RESOLVE ISSUE. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 150-157 MG/DL. CUSTOMER ADDRESSED THE OCCLUSION ALARMS BY CHANGING PUMP SUPPLIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 987168 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 00853052007264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR |