FDA Adverse Event
Injury
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 2863184
·
Received December 10, 2012
Report
- Report Number
- 2032227-2012-07972
- Event Type
- Injury
- Date Received
- December 10, 2012
- Date of Event
- November 23, 2012
- Report Date
- November 24, 2012
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ
- 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 SHE WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE EMERGENCY ROOM VISIT WAS 615 MG/DL. CUSTOMER STATED THAT SHE WAS DEHYDRATED, WITH NAUSEA, AND FREQUENT URINATION PRIOR TO HOSPITALIZATION. 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 | 64 YR | Hospitalization |