FDA Adverse Event
Malfunction
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 3896924
·
Received May 22, 2014
Report
- Report Number
- 3007981285-2014-00758
- Event Type
- Malfunction
- Date Received
- May 22, 2014
- Date of Event
- April 25, 2014
- Report Date
- April 25, 2014
- Manufacturer
- TANDEM DIABETES
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT RETURNING FOR EVALUATION. ATTEMPTS HAVE BEEN MADE TO OBTAIN ALL EVENT INFO. SHOULD NEW INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
CUSTOMER REPORTS THAT SHE WAS FILLING TUBING AND HAD NOT SEEN ANY INSULIN COME OUT. CUSTOMER BELIEVES CARTRIDGE IS LEAKING, BUT WAS NOT ABLE TO PINPOINT A SPECIFIC LOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306964 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES | 004628 | M002503 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |