FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
MDR report key: 1031857
·
Received April 16, 2008
Report
- Report Number
- 2032227-2008-00649
- Event Type
- Injury
- Date Received
- April 16, 2008
- Date of Event
- March 23, 2008
- Report Date
- April 1, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 PROD 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 STATED THAT HE WAS TREATED BY THE PARAMEDICS FOR A LOW BLOOD GLUCOSE READING OF 20 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE CUSTOMER STATED THAT HIS DR ADJUSTED THE BASAL RATES AND HIS BLOOD GLUCOSE LEVELS HAVE BEEN FINE SINCE THEN. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAS PRDGM INS V2.2 SK EN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-722NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |