FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP
MDR report key: 8571661
·
Received May 1, 2019
Report
- Report Number
- 3013756811-2019-23466
- Event Type
- Malfunction
- Date Received
- May 1, 2019
- Date of Event
- April 3, 2019
- Report Date
- May 1, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004798
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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. THE CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL RANGED FROM 150-370 MG/DL. SYSTEM CHECK COULD NOT BE PERFORMED AS THE OCCLUSIONS OCCURRED IN THE PAST. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 362227 | T:SLIM X2 INSULIN PUMP | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 1000096 | 00852162004798 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR |