FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4223097
·
Received November 4, 2014
Report
- Report Number
- 2032227-2014-47412
- Event Type
- Malfunction
- Date Received
- November 4, 2014
- Date of Event
- March 19, 2013
- Report Date
- March 19, 2013
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
UNIT RECEIVED WITH HIGH STOP CURRENT AND ALARMED A64 DURING SELF TEST DUE TO FAULTY Y1 AT RF BOARD. UNABLE TO VERIFY LOST SENSOR ALARMS DUE TO A64 ALARMS.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE INSULIN PUMP'S BATTERY LIFE WAS SHORTER THAN NORMAL. CUSTOMER REPORTED RECEIVING LOST SENSOR ALARMS. BLOOD GLUCOSE LEVEL WAS 91 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 705509 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-523LNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |