FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 4111182
·
Received September 23, 2014
Report
- Report Number
- 2032227-2014-22979
- Event Type
- Malfunction
- Date Received
- September 23, 2014
- Date of Event
- April 30, 2014
- Report Date
- April 30, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UNIT RECEIVED WITH HIGH STOP CURRENT DUE TO FAULTY C4 AT RF BOARD. UNIT RECEIVED WITH CRACKED RESERVOIR TUBE LIP. UNIT RECEIVED WITH MINOR SCRATCHED LCD WINDOW.(B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE INSULIN PUMP'S BATTERY LIFE WAS ONLY ABOUT ONE AND A HALF DAYS. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 589685 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-554WWL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |