FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4241042
·
Received November 10, 2014
Report
- Report Number
- 2032227-2014-50039
- Event Type
- Malfunction
- Date Received
- November 10, 2014
- Date of Event
- October 12, 2014
- Report Date
- October 13, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAS A BLANK DISPLAY, BATTERY OUT LIMIT. IT WAS ALSO REPORTED THAT THERE IS A CRACK AT THE BATTERY COMPARTMENT THREADING. TROUBLESHOOTING OCCURED. ADVISED INSULIN PUMP WOULD BE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 722226 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723LNAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR |