FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 2872720
·
Received December 13, 2012
Report
- Report Number
- 3004209178-2012-91370
- Event Type
- Malfunction
- Date Received
- December 13, 2012
- Date of Event
- December 2, 2012
- Report Date
- December 2, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
MOTOR ERROR ALARM DURING BASIC OCCLUSION TEST DUE TO FAULTY FORCE SENSOR. THE INSULIN PUMP PASSED MOTOR DISPLACEMENT TEST.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED MOTOR ERROR. THE BLOOD GLUCOSE READING WAS 250MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. ASSISTED THE FATHER TO RUN THE DISPLACEMENT TEST AND THE TEST FAILED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | OYC | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-523NAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR |