FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP
MDR report key: 10347302
·
Received July 30, 2020
Report
- Report Number
- 3013756811-2020-78438
- Event Type
- Malfunction
- Date Received
- July 30, 2020
- Date of Event
- July 7, 2020
- Report Date
- July 30, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004781
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 OCCLUSION ALARMS OCCURRED. REPORTEDLY, THE PUMP SUPPLIES WERE CHANGED TO ADDRESS THE ISSUE. ADDITIONALLY, IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. ULTIMATELY, THE ALTITUDE ALARM CLEARED BY RELOADING THE CARTRIDGE AND INSULIN DELIVERY WAS RESUMED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 200-239 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 807621 | T:SLIM X2 INSULIN PUMP | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 1000096 | 00852162004781 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |