FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4142047
·
Received October 4, 2014
Report
- Report Number
- 2032227-2014-33290
- Event Type
- Malfunction
- Date Received
- October 4, 2014
- Date of Event
- September 4, 2014
- Report Date
- September 4, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP PASSED THE REWIND, DISPLACEMENT, PRIME AND EXCESSIVE NO DELIVERY ALARM TESTS. NO EXCESSIVE NO DELIVERY ALARM WAS NOTED. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW.
Additional Manufacturer Narrative · 1
CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY. CUSTOMER'S BLOOD GLUCOSE READING WAS 286 MG/DL. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE OBSERVED. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 621603 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723LNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR |