FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 3984304
·
Received August 6, 2014
Report
- Report Number
- 2032227-2014-06198
- Event Type
- Malfunction
- Date Received
- August 6, 2014
- Date of Event
- July 15, 2011
- Report Date
- July 8, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS RECEIVED WITH A BUTTON ERROR ALARM AND NO BUTTON RESPONSE DUE TO MOISTURE-DAMAGED KEYPAD TRACES. THE INSULIN PUMP HAD A SCRATCHED DISPLAY WINDOW, A CRACKED DISPLAY WINDOW CORNER AND A CRACKED RESERVOIR TUBE LIP.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER RECEIVED A BUTTON ERROR ALARM ON THE INSULIN PUMP AND COULD NOT CLEAR THE ALARM. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 461746 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-722LWWL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |