FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 3133951
·
Received May 29, 2013
Report
- Report Number
- 2032227-2013-02187
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Date of Event
- April 26, 2013
- Report Date
- May 10, 2013
- 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
THE INSULIN PUMP WAS RECEIVED WITH FROZEN DISPLAY DUE TO CORROSION ON THE ELECTRONIC ASSEMBLY. BUTTONS FUNCTION PROPERLY WITH TESTING ELECTRONIC ASSEMBLY. NO MOISTURE DAMAGE FOUND ON THE KEYPAD TRACES. UNABLE TO PERFORMED THE ERROR ALARM DUE TO FROZEN DISPLAY.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THERE IS NO RESPONSE FROM ANY BUTTON ON THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235297 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-522LNAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |