FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 3093676
·
Received May 6, 2013
Report
- Report Number
- 2032227-2013-01654
- Event Type
- Malfunction
- Date Received
- May 6, 2013
- Date of Event
- April 8, 2013
- Report Date
- April 8, 2013
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS RECEIVED WITH PROTRUDED/LOOSE DRIVE SUPPORT DISK.
Description of Event or Problem · 1
CUSTOMER CALLED REGARDING THE FIELD NOTIFICATION LETTER. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP IS PROTRUDED. CUSTOMER REMINDED NOT TO MANIPULATE OR PUSH ON THE DRIVE SUPPORT CAP WHILE CONNECTED. THE INSULIN PUMP MUST BE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 196476 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-722RNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |