FDA Adverse Event
Injury
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 2090977
·
Received May 3, 2011
Report
- Report Number
- 2032227-2011-01149
- Event Type
- Injury
- Date Received
- May 3, 2011
- Date of Event
- April 26, 2011
- Report Date
- April 26, 2011
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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 REPORTED THAT SHE WENT TO THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE LEVELS OVER 600 MG/DL. THE INFUSION SET WAS REMOVED, AND THE CANNULA WAS BENT. THE CUSTOMER FELT THAT THE INSULIN PUMP WAS NOT THE CAUSE OF THE ELEVATED BLOOD GLUCOSE LEVELS, AND DECLINED TROUBLESHOOTING. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-722LNAP | A000114634 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Hospitalization | MMT-399| (B)(4) QUICK-SET PARADIGM INSULIN INFUSION SET: |