FDA Adverse Event
Injury
Summary report: N
PUMP MMT-715NAS PRDGM INS V2.1 SK EN
MDR report key: 1020329
·
Received March 26, 2008
Report
- Report Number
- 3004209178-2008-00215
- Event Type
- Injury
- Date Received
- March 26, 2008
- Date of Event
- November 9, 2007
- Report Date
- March 13, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS ABOUT THREE MONTHS AGO. THE CUSTOMER COULD ONLY RECALL WALING UP VERY SICK AND VOMITING PRIOR TO GOING TO THE HOSP. THE CUSTOMER REPORTED A BLOOD GLUCOSE READING OF 463 MG/DL. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-715NAS PRDGM INS V2.1 SK EN | INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-715NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |