FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 4192995
·
Received October 22, 2014
Report
- Report Number
- 2032227-2014-41597
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Date of Event
- September 25, 2014
- Report Date
- September 25, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PUMP RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE ELECTRONIC ASSEMBLY. PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS, BROKEN BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW. (B)(4).
Description of Event or Problem · 1
NO BLOOD GLUCOSE LEVELS WERE PROVIDED. IT WAS REPORTED THAT THE CUSTOMER COULD NOT START THE INSULIN PUMP WITH A NEW BATTERY. THE CUSTOMER ALSO REPORTED CRACKS ON THE INSULIN PUMP NEAR THE BATTERY COMPARTMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 672513 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-522WWL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |