FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INFUSION PUMP
MDR report key: 4130335
·
Received September 18, 2014
Report
- Report Number
- 2032227-2014-24686
- Event Type
- Malfunction
- Date Received
- September 18, 2014
- Date of Event
- September 3, 2014
- Report Date
- September 3, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS RECEIVED WITH A BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES. THE DEVICE WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW AND MISSING END CAP STICKER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTONS ERROR. THE BLOOD GLUCOSE READING WAS 129 MG/DL. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE OBSERVED. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 578884 | PARADIGM REAL-TIME INFUSION PUMP | OYC | MEDTRONIC MINIMED | MMT-522LNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |