FDA Adverse Event
Injury
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4150077
·
Received October 7, 2014
Report
- Report Number
- 2032227-2014-34830
- Event Type
- Injury
- Date Received
- October 7, 2014
- Date of Event
- July 8, 2014
- Report Date
- September 8, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO
- 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.(B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED HAVING UNEXPLAINED HIGH BLOOD GLUCOSE LEVELS FOR SEVERAL MONTHS LEADING UP TO THE CALL. BLOOD GLUCOSE LEVEL WAS 441 MG/DL AT THE TIME OF THE CALL. CUSTOMER REPORTED BEING THIRSTY AND URINATING FREQUENTLY. TROUBLESHOOTING SHOWED THAT THE INSULIN PUMP WAS FUNCTIONING PROPERLY. CUSTOMER REPORTED THAT MENOPAUSE MAY BE A CONTRIBUTING FACTOR TO HER ELEVATED BLOOD GLUCOSE LEVELS. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 628096 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-523NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |