FDA Adverse Event
Injury
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 2863196
·
Received December 10, 2012
Report
- Report Number
- 2032227-2012-07977
- Event Type
- Injury
- Date Received
- December 10, 2012
- Date of Event
- November 24, 2012
- Report Date
- November 25, 2012
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP PASSED ALL FUNCTIONAL TEST, INCLUDING PRIME, DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, AND EXCESSIVE NO DELIVERY ALARM TEST.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT HE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS OVER 600 MG/DL. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | OYC | OYC | MEDTRONIC MINIMED | MMT-723LNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Hospitalization |