FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR
MDR report key: 1192433
·
Received October 7, 2008
Report
- Report Number
- 3004209178-2008-00821
- Event Type
- Injury
- Date Received
- October 7, 2008
- Date of Event
- September 23, 2008
- Report Date
- September 23, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- LZG
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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. 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 FOR HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 236MG/DL. TROUBLESHOOTING WAS NOT PERFORMED AT TIME OF CALL BECAUSE THE CUSTOMER'S MOTHER DID NOT HAVE SUPPLIES. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR | INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |