FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 5003881
·
Received August 14, 2015
Report
- Report Number
- 2032227-2015-29760
- Event Type
- Malfunction
- Date Received
- August 14, 2015
- Date of Event
- July 13, 2015
- Report Date
- July 23, 2015
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
PUMP RECEIVED WITH NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES.
Description of Event or Problem · 1
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP'S ACT BUTTON WAS STICKING AND RESPONDING INTERMITTENTLY. THE CUSTOMER STATED THAT THE DEVICE MAY HAVE BEEN EXPOSED TO SWEAT. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS NOT PROVIDED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 538177 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-722LNAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR |