FDA Adverse Event
Injury
Summary report: N
PUMP MMT-712LNAP PRDGM INS PL EN US LN
MDR report key: 1231878
·
Received November 12, 2008
Report
- Report Number
- 2032227-2008-01944
- Event Type
- Injury
- Date Received
- November 12, 2008
- Date of Event
- October 25, 2008
- Report Date
- November 1, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K031390
- 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 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 STATED THAT SHE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE CUSTOMER STATED THAT THE ELEVATED BLOOD GLUCOSE LEVELS WERE CAUSED BY THE FLU AND WEARING THE INFUSION SET FOR THREE DAYS. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-712LNAP PRDGM INS PL EN US LN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-712LNAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |