FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4200601
·
Received October 24, 2014
Report
- Report Number
- 2032227-2014-42665
- Event Type
- Malfunction
- Date Received
- October 24, 2014
- Date of Event
- September 17, 2014
- Report Date
- September 24, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INSULIN PUMP DRIVE SUPPORT DISK WAS FOUND SLIGHTLY LOOSE. INSULIN PUMP PASSED REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST, CRACKED CASE AT RESERVOIR TUBE WINDOW CORNERS AND DISPLACEMENT TEST. INSULIN PUMP HAD A CRACKED CASE ON DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS AND RESERVOIR TUBE WINDOW.
Additional Manufacturer Narrative · 1
(B)(4). 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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS LOOSE. CUSTOMER ALSO MENTIONED THAT THE RESERVOIR HAD A CRACK. NO FURTHER INFORMATION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679136 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723NAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |