FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 3112634
·
Received May 14, 2013
Report
- Report Number
- 3004209178-2013-93433
- Event Type
- Malfunction
- Date Received
- May 14, 2013
- Date of Event
- February 6, 2013
- Report Date
- April 30, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP ALARM MOTOR ERROR DURING THE BASIC OCCLUSION TEST, DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNIT WAS RECEIVED WITH MISSING END CAP STICKER.
Description of Event or Problem · 1
CUSTOMER CALLED TO REPORT THAT SHE HAD HIGH BLOOD GLUCOSE AND THE INSULIN PUMP IS ALARMING MOTOR ERROR AND SQUIRTING THE INSULIN OUT DURING THE MANUAL PRIME. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212669 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-522NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |