FDA Adverse Event
Injury
Summary report: N
WEB-BASED DATA MANAGEMENT
MDR report key: 2001649
·
Received February 18, 2011
Report
- Report Number
- 2032227-2011-00470
- Event Type
- Injury
- Date Received
- February 18, 2011
- Date of Event
- February 8, 2011
- Report Date
- February 8, 2011
- Manufacturer
- MEDTORNIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P989922
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNK 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 ALSO MFR REPORT NUMBER 2032227-2011-00471.
Description of Event or Problem · 1
A NURSE FROM A DOCTOR'S OFFICE CALLED TO GO OVER THE CARELINK REPORTS. THE NURSE STATED THAT THE PARAMEDICS WERE CALLED TO THE CUSTOMER'S HOUSE IN THE MORNING DUE TO LOW BLOOD GLUCOSE LEVELS. FOUND THAT THE CUSTOMER HAD ACCIDENTALLY SET A BASAL RATE PATTERN OF 18.0 UNITS FOR FIVE HOURS. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WEB-BASED DATA MANAGEMENT | CGMS SOFTWARE | MDS | MEDTORNIC MINIMED | MMT-7333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |