FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 7899171
·
Received September 21, 2018
Report
- Report Number
- 3013756811-2018-33233
- Event Type
- Malfunction
- Date Received
- September 21, 2018
- Date of Event
- September 7, 2018
- Report Date
- September 21, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN ADDITIONAL LOT NUMBER WAS REPORTED (LOT # M022021). 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.
Additional Manufacturer Narrative · 1
THE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED MALFUNCTION WAS IDENTIFIED IN THE PUMP LOGS; HOWEVER, NO FAILURE WAS IDENTIFIED AS THE CARTRIDGE WAS NOT RETURNED. ADDITIONALLY, A DIFFERENT ISSUE WAS IDENTIFIED.
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE CARTRIDGE ALARMS (ALARM 1) OCCURRED WITH MULTIPLE CARTRIDGES DURING THE LOAD SEQUENCE. THE CUSTOMER'S BLOOD GLUCOSE WAS 209 MG/DL. REPORTEDLY, THE CUSTOMER HAD MANUAL INJECTIONS AS ALTERNATE INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 738055 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | M116717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |