FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3970032
·
Received July 31, 2014
Report
- Report Number
- 3004209178-2014-88396
- Event Type
- Malfunction
- Date Received
- July 31, 2014
- Date of Event
- July 1, 2014
- Report Date
- July 1, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP HAD A BROKEN BATTERY CAP. THE BLOOD GLUCOSE READING WAS 173 MG/DL. THE CUSTOMER STATED THAT THE LITTLE TINY SILVER PIECE WHERE THE BATTERY MAKES CONTACT FELL OFF OF THE CAP. CONFIRMED WITH THE CUSTOMER THAT THERE WAS NO OTHER DAMAGE TO THE DEVICE OBSERVED. ADVISED REPLACEMENT OF THE BATTERY CAP AND DISCONTINUATION UNTIL IT ARRIVES. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 446836 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |