FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3130874
·
Received May 24, 2013
Report
- Report Number
- 3004209178-2013-94064
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Date of Event
- May 9, 2013
- Report Date
- May 9, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED DURING THE PRIME TEST AS A RESULT OF A PROTRUDED/LOOSE DRIVE SUPPORT DISK.
Description of Event or Problem · 1
THE CUSTOMER REPORTED REGARDING ISSUES DURING PRIME/REWIND. THE BLOOD GLUCOSE READING WAS 350MG/DL. THE CALLER STATED THAT INSULIN SQUIRTED OUT, AND THE INSULIN PUMP ALARMED. THE CUSTOMER MENTIONED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231396 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723NAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |