FDA Adverse Event
Malfunction
Summary report: N
PARADIGM INSULIN INFUSION PUMP
MDR report key: 2984116
·
Received February 28, 2013
Report
- Report Number
- 3004209178-2013-91499
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- December 24, 2012
- Report Date
- February 21, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LZG
- PMA / PMN Number
- K040676
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK.
Description of Event or Problem · 1
THE CUSTOMER REPORTED REGARDING ISSUES DURING PRIME/REWIND. THE BLOOD GLUCOSE READING WAS 261MG/DL. THE CALLER STATED THAT INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS, AND THE INSULIN PUMP ALARMED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85824 | PARADIGM INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-715NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |