FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3972076
·
Received July 31, 2014
Report
- Report Number
- 2032227-2014-05089
- Event Type
- Malfunction
- Date Received
- July 31, 2014
- Date of Event
- June 8, 2014
- Report Date
- July 2, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND NO DELIVERY TESTS. THE DEVICE WAS RECEIVED WITH STRIPPED BATTERY CAP AT COIN SLOT AREA, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, CRACKED DISPLAY WINDOW CORNER, SCRATCHED LCD WINDOW, AND MISSING END CAP STICKER.
Description of Event or Problem · 1
CUSTOMER REPORTED HE IS UNABLE TO TAKE OF THE BATTERY CAP FROM THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 293 MG/DL, TREATED WITH A BOLUS. TROUBLESHOOTING WAS PERFORMED. CUSTOMER ATTEMPTED TO REMOVE THE BATTERY CAP WITH A QUARTER AND LARGE SCREWDRIVER AND WAS UNABLE TO DO SO. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 448325 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-723NAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR |