FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722NAP PRDGM INS V2.2 PL EN
MDR report key: 1210275
·
Received October 22, 2008
Report
- Report Number
- 3004209178-2008-00863
- Event Type
- Injury
- Date Received
- October 22, 2008
- Date of Event
- October 7, 2008
- Report Date
- October 7, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- LZG
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
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'S MOTHER STATED THAT THE CUSTOMER WAS HOSPITALIZED, DUE TO VOMITING AND DIABETIC KETOACIDOSIS. THE REPORTED BLOOD GLUCOSE READING WAS 700 MG/DL. THE CUSTOMER'S MOTHER STATED THAT THE INSULIN PUMP HAD ALARMED NO DELIVERY. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE PRIME TEST. 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 OPERATIONS MED-REL | MMT-722NAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |