FDA Adverse Event
Injury
Summary report: N
MODEL NOT SPECIFIED
MDR report key: 2161770
·
Received July 8, 2011
Report
- Report Number
- 2032227-2011-01664
- Event Type
- Injury
- Date Received
- July 8, 2011
- Date of Event
- June 20, 2011
- Report Date
- June 20, 2011
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNKNOWN 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 FOLLOWING INFORMATION WAS REPORTED BY THE CUSTOMER'S ATTORNEY'S OFFICE: THE CUSTOMER WAS HOSPITALIZED AS A RESULT OF ALLEGEDLY RECEIVING IMPROPER AMOUNTS OF INSULIN WHILE USING THE INSULIN PUMP, CONTINUOUS GLUCOSE MONITORING SYSTEM, AND INFUSION SETS. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MODEL NOT SPECIFIED | INSULIN INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-XXX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Hospitalization |