FDA Adverse Event
Injury
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 2101552
·
Received May 20, 2011
Report
- Report Number
- 2032227-2011-01294
- Event Type
- Injury
- Date Received
- May 20, 2011
- Date of Event
- August 1, 2008
- Report Date
- May 13, 2011
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 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 MENTIONED THAT SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS OVER 900 MG/DL BACK IN (B)(6) OF 2008. THE CUSTOMER COULD NOT RECALL ANY DETAILS REGARDING THE HOSPITALIZATION. 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-722PNAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Hospitalization |