FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4090508
·
Received September 15, 2014
Report
- Report Number
- 2032227-2014-23158
- Event Type
- Malfunction
- Date Received
- September 15, 2014
- Date of Event
- June 18, 2014
- Report Date
- June 18, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
CRACKED RESERVOIR TUBE LIP, CRACKED BATTERT TUBE THREADS, CRACKED RESERVOIR TUBE AND CRACKED RESERVOIR WINDOW NOTED DURING VISUAL INSPECTION. DAMAGE BATTERY CAP COIN SLOT NOTED.
Description of Event or Problem · 1
CUSTOMER CALLED TO REPORT THE INSULIN PUMP HAD A CRACK AROUND THE RESERVOIR COMPARTMENT. BLOOD GLUCOSE READING WAS 95 MG/DL. THE DAMAGE OCCURRED WHILE THE CUSTOMER WAS GOING DOWN THE SCAFFOLDING. ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 570305 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-523LNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |