FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 3192773
·
Received June 27, 2013
Report
- Report Number
- 3004209178-2013-95101
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Date of Event
- June 8, 2013
- Report Date
- June 8, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
THE INFUSION PUMP ALARM DURING THE PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK.
Description of Event or Problem · 1
IT WAS REPORTED BY CUSTOMER'S SPOUSE, THAT THE INSULIN PUMP ALARMED, AND INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER'S BLOOD GLUCOSE READING IS 90 MG/DL. THE DRIVE SUPPORT CAP IS PROTRUDED. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291806 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-722NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |