FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4200595
·
Received October 24, 2014
Report
- Report Number
- 2032227-2014-42655
- Event Type
- Malfunction
- Date Received
- October 24, 2014
- Date of Event
- September 24, 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
- MI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Additional Manufacturer Narrative · 1
INSULIN PUMP HAD AN INTERMITTENT BUTTON RESPONSE DUE TO CORRODED ACT BUTTON ON KEYPAD TRACES. NO BUTTON ERROR ALARM DURING TESTING. INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW AND CRACKED RESERVOIR TUBE LIP.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR WHEN ATTEMPTING TO BOLUS. CUSTOMER STATED THAT THE BUTTONS WERE STUCK. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 197 MG/DL. NO FURTHER INFORMATION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679141 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723LNAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |