FDA Adverse Event
Injury
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 2033968
·
Received March 18, 2011
Report
- Report Number
- 2032227-2011-00698
- Event Type
- Injury
- Date Received
- March 18, 2011
- Date of Event
- September 1, 2010
- Report Date
- March 5, 2011
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
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.
Description of Event or Problem · 1
THE CUSTOMER CALLED TO REPORT A FROZEN SCREEN AS WELL AS BEING HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE LEVELS OVER 800 MG/DL. THE CUSTOMER STATED THAT SHE EXPERIENCED BENT CANNULAS PRIOR TO BEING HOSPITALIZED. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-523LNAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Hospitalization |