FDA Adverse Event
Injury
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3920285
·
Received July 8, 2014
Report
- Report Number
- 3004209178-2014-86617
- Event Type
- Injury
- Date Received
- July 8, 2014
- Date of Event
- June 13, 2014
- Report Date
- June 16, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
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. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.
Description of Event or Problem · 1
CUSTOMER'S MOTHER REPORTED THE HOSPITALIZATION DUE TO DIABETES KETOACIDOSIS. THE CUSTOMER WAS EXPERIENCING EXTREME THIRST, NAUSEA, VOMITING AND FREQUENT URINATION. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS OVER 700 MG/DL. CUSTOMER PLAYS BASEBALL AND THE CANNULA MAY HAVE KINKED. HOSPITAL TREATED WITH IV DRIP AND MANUAL INJECTIONS. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 397658 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Hospitalization |