FDA Adverse Event
Injury
Summary report: N
PUMP MMT-522NAS PRDGM INS V2.2 SK EN
MDR report key: 1000458
·
Received February 21, 2008
Report
- Report Number
- 2032227-2008-00365
- Event Type
- Injury
- Date Received
- February 21, 2008
- Date of Event
- February 9, 2008
- Report Date
- February 11, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- P980022
- 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 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
IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS NOT REPORTED. IT WAS REPORTED THAT AT THE TIME OF THE EVENT, THE AUTO OFF FEATURE IN THE INSULIN PUMP HAD BEEN TURNED ON FOR THIRTEEN HOURS. TROUBLESHOOTING WAS PERFORMED AND THE PROGRAMMING WAS ACCURATE. THE INSULIN PUMP 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-522NAS PRDGM INS V2.2 SK EN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-522NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization |