FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
MDR report key: 10489010
·
Received September 3, 2020
Report
- Report Number
- 3013756811-2020-94768
- Event Type
- Malfunction
- Date Received
- September 3, 2020
- Date of Event
- August 19, 2020
- Report Date
- September 3, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613212
- PMA / PMN Number
- DEN180058
- 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 RESISTANCE WAS FELT WHEN FILLING THE CARTRIDGE DURING THE LOAD SEQUENCE. CUSTOMER WAS ABLE TO FILL THE CARTRIDGE WITH THE EXISTING NEEDLE. CUSTOMER¿S BLOOD GLUCOSE RANGED 200-215 MG/DL. IN ADDITION, IT WAS REPORTED THAT THE CARTRIDGE LEAKED. REPORTEDLY, THE CUSTOMER DID NOT REMOVE AIR FROM THE CARTRIDGE PRIOR TO FILLING THE CARTRIDGE WITH INSULIN. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER HOW TO PROPERLY LOAD A CARTRIDGE. CUSTOMER ACKNOWLEDGED AND LOADED A NEW CARTRIDGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 955024 | T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | INSULIN: NOVOLOG, INFUSION SET: TRUSTEEL |