FDA Adverse Event
Injury
Summary report: N
PUMP MMT-515LNAB PRDGM INS V2.1 BL EN
MDR report key: 1192427
·
Received October 7, 2008
Report
- Report Number
- 2032227-2008-01748
- Event Type
- Injury
- Date Received
- October 7, 2008
- Date of Event
- September 20, 2008
- Report Date
- September 23, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K040676
- 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS. NO BLOOD GLUCOSE LEVEL WAS PROVIDED AT THE TIME OF THE CALL. TROUBLESHOOTING WAS PERFORMED AND THE BASAL RATES AND SETTINGS IN THE INSULIN PUMP WERE CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TESTS AND PASSED. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-515LNAB PRDGM INS V2.1 BL EN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-515LNAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |