FDA Adverse Event
Injury
Summary report: N
PUMP MMT-715LNAP PRDGM INS V2.1 PL EN
MDR report key: 1063161
·
Received June 20, 2008
Report
- Report Number
- 2032227-2008-01033
- Event Type
- Injury
- Date Received
- June 20, 2008
- Date of Event
- June 9, 2008
- Report Date
- June 11, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K040676
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- 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.
Description of Event or Problem · 1
THE CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 300 MG/DL. THE CUSTOMER STATED THAT SHE WAS NAUSEATED AND VOMITING BEFORE GOING TO THE HOSPITAL. THE CUSTOMER ALSO STATED THAT ALL PROGRAMMING IS ACCURATE. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-715LNAP PRDGM INS V2.1 PL EN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-715LNAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |