FDA Adverse Event
Injury
Summary report: N
PARADIGM INSULIN INFUSION PUMP
MDR report key: 2031047
·
Received March 16, 2011
Report
- Report Number
- 2032227-2011-00670
- Event Type
- Injury
- Date Received
- March 16, 2011
- Date of Event
- January 25, 2011
- Report Date
- March 1, 2011
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
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.
Description of Event or Problem · 1
THE CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE LEVELS BETWEEN 700 AND 800 MG/DL. THE CUSTOMER STATED THAT SHE ALSO SUFFERED A HEART ATTACK DUE TO THE DIABETIC KETOACIDOSIS. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-522LNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization |