FDA Adverse Event
Injury
Summary report: N
PUMP MMT-712LNAB PRDGM INS BL EN US LN
MDR report key: 1031178
·
Received April 17, 2008
Report
- Report Number
- 2032227-2008-00660
- Event Type
- Injury
- Date Received
- April 17, 2008
- Date of Event
- April 2, 2008
- Report Date
- April 4, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K031390
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- NOT APPLICABLE
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'S MOTHER STATED THAT THE CUSTOMER WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE READING OF 500 MG/DL. THE CUSTOMER WAS ALSO VOMITING. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP ALSO PASSED THE PRIME AND HIGH PRESSURE TESTS. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-712LNAB PRDGM INS BL EN US LN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-712LNAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |