FDA Adverse Event
Injury
Summary report: N
PUMP MMT-715NAS PRDGM INS V2.1 SK EN
MDR report key: 1231872
·
Received November 12, 2008
Report
- Report Number
- 3004209178-2008-00950
- Event Type
- Injury
- Date Received
- November 12, 2008
- Date of Event
- October 28, 2008
- Report Date
- October 30, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- LZG
- PMA / PMN Number
- K040676
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, 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 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 WIFE REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE REPORTED BLOOD GLUCOSE READING WAS 468 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE PRIME TEST PASSED. A TUBING CLAMP WAS NOT AVAILABLE TO PERFORM THE HIGH PRESSURE TEST. THE CUSTOMER WAS SENT A TUBING CLAMP AND ADVISED TO CALL BACK TO PERFORM THE HIGH PRESSURE TEST. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-715NAS PRDGM INS V2.1 SK EN | INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-715NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |