FDA Adverse Event
Injury
Summary report: N
PARADIGM INSULIN INFUSION PUMP MMT-712LNAP
MDR report key: 1973896
·
Received January 20, 2011
Report
- Report Number
- 2032227-2011-00185
- Event Type
- Injury
- Date Received
- January 20, 2011
- Date of Event
- January 3, 2011
- Report Date
- January 7, 2011
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K031390
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, 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 DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 431 MG/DL. THE CUSTOMER STATED THAT SHE PASSED OUT IN THE DRIVEWAY OF HER HOME. THE CUSTOMER ALSO STATED THAT THE DEVICE ALARMED NO DELIVERY MULTIPLE TIMES. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM INSULIN INFUSION PUMP MMT-712LNAP | INSULIN INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-712LNAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Hospitalization |