FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4141762
·
Received October 4, 2014
Report
- Report Number
- 2032227-2014-33525
- Event Type
- Malfunction
- Date Received
- October 4, 2014
- Date of Event
- September 3, 2014
- Report Date
- September 4, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- PATIENT
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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Additional Manufacturer Narrative · 1
THE INSULIN PUMP HAD A CRACKED CASE AT A DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED BELT CLIP SLOT AND CRACKED BATTERY TUBE THREADS.
Description of Event or Problem · 1
CUSTOMER REPORTED THERE WAS A CRACK ON THE INSULIN PUMP'S DISPLAY. THE CUSTOMER STATED SHE HAD FALLEN AND BUMPED THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 105 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 621084 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-523RNAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |