FDA Adverse Event
Malfunction
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 3896928
·
Received May 22, 2014
Report
- Report Number
- 3007981285-2014-00763
- Event Type
- Malfunction
- Date Received
- May 22, 2014
- Date of Event
- April 24, 2014
- Report Date
- April 24, 2014
- Manufacturer
- TANDEM DIABETES
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN REC'D FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A F/U MDR WILL BE FILED.
Description of Event or Problem · 1
REC'D INFO REGARDING A SEPARATION BETWEEN THE PATIENT LINE (PIGTAIL) AND THE LUER LOCK. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307027 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES | 004628 | M000827 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |