FDA Adverse Event
Injury
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3121133
·
Received May 20, 2013
Report
- Report Number
- 3004209178-2013-93732
- Event Type
- Injury
- Date Received
- May 20, 2013
- Date of Event
- April 23, 2013
- Report Date
- April 25, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE DEVICE HAD SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, AND CRACKED RESERVOIR TUBE LIP.
Description of Event or Problem · 1
THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OVER 600MG/DL. THE CUSTOMER EXPERIENCED VOMITING, DIZZINESS, AND WAS UNABLE TO WALK. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER MENTIONED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING THE BASAL. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221495 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723NAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Hospitalization |