FDA Adverse Event
Injury
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 3093728
·
Received May 6, 2013
Report
- Report Number
- 2032227-2013-01672
- Event Type
- Injury
- Date Received
- May 6, 2013
- Date of Event
- March 26, 2013
- Report Date
- April 9, 2013
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.
Description of Event or Problem · 1
CUSTOMER REPORTED A HOSPITALIZATION DUE TO DIABETIC KETOACIDOSIS. CUSTOMER EXPERIENCED VOMITING AND EXTREME THIRST. THE BLOOD GLUCOSE READING AT TIME OF EVENT WAS OVER 500 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT WORKING PROPERLY. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 196146 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-722LNAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization |