FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3945843
·
Received July 21, 2014
Report
- Report Number
- 2032227-2014-04731
- Event Type
- Malfunction
- Date Received
- July 21, 2014
- Date of Event
- June 20, 2014
- Report Date
- June 20, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
.
Additional Manufacturer Narrative · 1
THE INSULIN PUMP ALARMED DURING THE SELF TEST DUE TO A FAULTY CONNECTOR ON THE RF BOARD. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP AND A CRACKED BELT CLIP SLOT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN ALARM ON HER INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 112 MG/DL. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 426067 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-723LNAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |