FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
MDR report key: 1874013
·
Received October 15, 2010
Report
- Report Number
- 3004209178-2010-83141
- Event Type
- Malfunction
- Date Received
- October 15, 2010
- Date of Event
- September 26, 2010
- Report Date
- October 3, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE OF 340 MG/DL FOR THE PAST WEEK. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER TREATED HIS GLUCOSE LEVEL WITH A BOLUS. THE TIME AND THE PROGRAMMING WERE CORRECT. RAN A FIXED PRIME TEST AND THE INSULIN DID NOT EXIT. PERFORMED A HIGH PRESSURE TEST AND THE DEVICE DID NOT ALARM. INSTRUCTED THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO HIS BACK UP PLAN. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAS PRDGM INS V2.2 SK EN | INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |