FDA Adverse Event
Injury
Summary report: N
PUMP MMT-723NAS PRDGM INSULIN SMOKE EN
MDR report key: 1812263
·
Received August 20, 2010
Report
- Report Number
- 3004209178-2010-82568
- Event Type
- Injury
- Date Received
- August 20, 2010
- Date of Event
- July 19, 2010
- Report Date
- July 20, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- LZG
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST. THE DEVICE WAS PROGRAMMED WITH MULTIPLE BOLUSES AND BASALS AND ALL REGISTERED PROPERLY IN THE BOLUS AND DAILY TOTAL HISTORY. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP WAS GIVING A 25 UNITS OF INSULIN, BUT THE CUSTOMER DENIED. IT WAS STATED THAT THE CUSTOMER CHECKED THE CARELINK AND FOUND THAT THE BOLUS WAS DELIVERED THROUGH THE BOLUS WIZARD. NO FURTHER INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-723NAS PRDGM INSULIN SMOKE EN | INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-723NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization |