FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS
MDR report key: 8686175
·
Received June 11, 2019
Report
- Report Number
- 2032227-2019-14439
- Event Type
- Malfunction
- Date Received
- June 11, 2019
- Date of Event
- January 6, 2019
- Report Date
- June 11, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- UDI-DI
- 00643169513099
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A TEST RESERVOIR WAS INSTALLED AND DID NOT LOCK IN PLACE DUE TO COMPLETELY BROKEN RESERVOIR TUBE LIP. UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO COMPLETELY BROKEN RESERVOIR TUBE LIP. DEVICE HAD MISSING RESERVOIR TUBE O-RING.
Description of Event or Problem · 1
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DAMAGED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THE RESERVOIR RING WAS DAMAGED. CUSTOMER STATED THAT THE RESERVOIR RING DOES LOCK IN PLACE WHEN INSERTED IN THE INSULIN PUMP. ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 482302 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-523RNAS | A1523RNASJ | 00643169513099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |