FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 7625762
·
Received June 21, 2018
Report
- Report Number
- 3013756811-2018-20688
- Event Type
- Malfunction
- Date Received
- June 21, 2018
- Date of Event
- May 27, 2018
- Report Date
- June 21, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. DEVICE NOT RETURNED.
Additional Manufacturer Narrative · 1
THE FAILURE INVESTIGATION HAS BEEN PERFORMED AND THE ALLEGED ISSUE WAS VERIFIED IN THE PUMP LOGS; HOWEVER, INVESTIGATION COULD NOT BE COMPLETED AS THE CARTRIDGE WAS NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE, INTERMITTENT OCCLUSION ALARMS OCCURRED. BLOOD GLUCOSE 231-255 MG/DL. REPORTEDLY, CUSTOMER REVERTED TO AN ALTERNATE PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 466615 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | INFUSION SET: COMFORT SHORT, INSULIN: HUMALOG |