FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP
MDR report key: 7642417
·
Received June 27, 2018
Report
- Report Number
- 3013756811-2018-21287
- Event Type
- Malfunction
- Date Received
- June 27, 2018
- Date of Event
- March 4, 2018
- Report Date
- June 27, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, 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 INTERMITTENT OCCLUSION ALARMS OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED FROM 190-240 MG/DL. REPORTEDLY, THE TEMPERATURE OF THE PUMP CHANGED PRIOR TO WHEN THE OCCLUSION ALARMS WERE DECLARED. DURING SYSTEM CHECK, THE INFUSION TUBING WAS IDENTIFIED AS A POSSIBLE CAUSE BUT COULD NOT BE CONFIRMED. THE CUSTOMER INDICATED THAT THE INFUSION TUBING WOULD BE CHANGED AND INSULIN DELIVERY WOULD BE RESUMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 483746 | T:SLIM X2 INSULIN PUMP | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 1000096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |