FDA Adverse Event
Malfunction
Summary report: N
DELTEC COZMO INSULIN PUMP
MDR report key: 1080112
·
Received July 17, 2008
Report
- Report Number
- 2183502-2008-00188
- Event Type
- Malfunction
- Date Received
- July 17, 2008
- Date of Event
- June 18, 2008
- Report Date
- July 15, 2008
- Manufacturer
- SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
- Product Code
- LZG
- Removal / Correction Number
- 2183502-03/10/08-005-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
THE RPTR CALLED FOR A REPLACEMENT DEVICE DUE TO SUSPECTED DELIVERY ISSUES. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTEC COZMO INSULIN PUMP | INSULIN PUMP | LZG | SMITHS MEDICAL MD (FORMERLY DELTEC, INC) | 1800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |