FDA Adverse Event
Injury
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3023036
·
Received March 27, 2013
Report
- Report Number
- 3004209178-2013-92147
- Event Type
- Injury
- Date Received
- March 27, 2013
- Date of Event
- March 16, 2013
- Report Date
- March 16, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- 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. PLEASE SEE MEDWATCH REPORT # 3004209178-2013-92148.
Description of Event or Problem · 1
THE CUSTOMER REPORTED HAVING LOW BLOOD GLUCOSE OF 40S MG/DL, AND THE PARAMEDICS WERE CALLED TO HER HOME. THE CUSTOMER STATED SHE WAS DISCONNECTED FROM THE INSULIN PUMP, AND BY THE TIME THEY ARRIVED HER BLOOD GLUCOSE WAS 130MG/DL. THE CALLER STATED THAT THEY GAVE HER INSULIN, AND ALSO SHE ATE SOME SUGAR. ASSISTED THE CUSTOMER TO RUN A SELF TEST AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126254 | 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 | 44 YR | Required Intervention |