FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 2970490
·
Received February 20, 2013
Report
- Report Number
- 3004209178-2013-91154
- Event Type
- Malfunction
- Date Received
- February 20, 2013
- Date of Event
- January 26, 2013
- Report Date
- February 8, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH AN ALARM AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. THE DEVICE HAD CRACKED RESERVOIR TUBE AND SCRATCHED DISPLAY WINDOW.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER HAD ISSUES DURING PRIME/REWIND. THE BLOOD GLUCOSE READING WAS 228MG/DL. THE CALLER STATED THAT INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS, AND THE INSULIN PUMP ALARMED. ADVISED THE FATHER THAT THE INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74986 | 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 | 14 YR |