FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB
MDR report key: 14509930
·
Received May 26, 2022
Report
- Report Number
- 2032227-2022-195244
- Event Type
- Malfunction
- Date Received
- May 26, 2022
- Date of Event
- February 1, 2012
- Report Date
- May 25, 2022
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- UDI-DI
- 0000006139949043
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
(B)(4). THIS RECORD WAS CONVERTED. FOR ADDITIONAL INFORMATION ABOUT THE ANALYSIS, PLEASE SEE SAP. UNIT HAD MOTOR ERROR ON REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. UNABLE TO VERIFY E-70 ALARM IN HISTORY SCREEN DUE TO MOTOR ERROR DURING REWINDING. HD (B)(6) 2012.
Description of Event or Problem · 0
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER WAS UNABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER PERFORMED SELF TEST AND THE TEST PASSED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2451036 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723NAB | A5723NABJ | 0000006139949043 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male |