FDA Adverse Event
Injury
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3002227
·
Received March 13, 2013
Report
- Report Number
- 2032227-2013-00964
- Event Type
- Injury
- Date Received
- March 13, 2013
- Date of Event
- February 22, 2013
- Report Date
- February 22, 2013
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO FAULTY FORCE SENSOR. UNABLE TO PERFORMED THE BASIC OCCLUSION, OCCLUSION, EXCESSIVE NO DELIVERY ALARM DUE TO PRIME FILL ANOMALY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED IN INTENSIVE CARE UNIT DUE TO HIGH BLOOD GLUCOSE AND DKA. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS 624 MG/DL. CALLER STATED THAT THE CUSTOMER HAD NAUSEA AND WAS THIRSTY PRIOR TO HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105117 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-723LNAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Hospitalization |