FDA Adverse Event
Injury
Summary report: N
PUMP MMT-512LNAP PRDGM INS PL EN US LN
MDR report key: 1133359
·
Received August 22, 2008
Report
- Report Number
- 2032227-2008-01446
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- August 5, 2008
- Report Date
- August 12, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K030531
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNKNOWN 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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 425 MG/DL. THE CUSTOMER STATED THAT THE INFUSION SET WAS NOT CHANGED PRIOR TO HER HOSPITALIZATION. THE CUSTOMER DECLINED TO TROUBLESHOOT HIS INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-512LNAP PRDGM INS PL EN US LN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-512LNAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |