FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722NAP PRDGM INS V2.2 PL EN
MDR report key: 1063313
·
Received June 18, 2008
Report
- Report Number
- 3004209178-2008-00421
- Event Type
- Injury
- Date Received
- June 18, 2008
- Date of Event
- June 3, 2008
- Report Date
- June 3, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATONS MED-REL
- 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
IT WAS STATED BY THE DIABETES CONSULTANT THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS AS WELL AS HEART AND KIDNEY PROBLEMS. THE CONSULTANT WANTED TO MAKE SURE THAT THE INSULIN PUMP WAS WORKING PROPERLY. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAP PRDGM INS V2.2 PL EN | INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATONS MED-REL | MMT-722NAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |