FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4150281
·
Received October 7, 2014
Report
- Report Number
- 2032227-2014-34302
- Event Type
- Malfunction
- Date Received
- October 7, 2014
- Date of Event
- January 28, 2014
- Report Date
- September 9, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INSULIN PUMP WAS RECEIVED WITH ERROR ALARM AFTER BATTERY CHANGE DUE TO VOLTAGE LEAKS (COOPER CAP) ON INTERFACE BOARD. THE DEVICE HAD MEMORY LOST DUE TO ANOMALY. THE DEVICE HAD CRACKED BATTERY TUBE THREADS, CRACKED BELT CLIP SLOT AT BATTERY TUBE THREADS AREA AND CRACKED RESERVOIR TUBE LIP.
Description of Event or Problem · 1
CUSTOMER REPORTED HER INSULIN PUMP ALARMING EVERY TIME SHE CHANGES HER BATTERY. SHE ALSO STATED THE ALARM FORCES HER TO RESET HER TIME AND DATE. THE CUSTOMER'S BLOOD GLUCOSE WAS 110 MG/DL. THE CUSTOMER STATED HER TEMP BASAL WAS NOT PROGRAMMED BEFORE THE ALARM OCCURRED. THE CUSTOMER REQUESTED TO REPLACE HER INSULIN PUMP. NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 629697 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723NAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |