FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 4233472
·
Received November 6, 2014
Report
- Report Number
- 2032227-2014-48591
- Event Type
- Malfunction
- Date Received
- November 6, 2014
- Date of Event
- June 19, 2012
- Report Date
- October 13, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
NO BUTTON ERROR ALARM NOTED. PUMP HAS INTERMITTENT BUTTON RESPONSE DUE TO CORRODED DAMAGE ON KEYPAD TRACES. PUMP RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED WINDOW AND CRACKED BATTERY TUBE THREADS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER STATED THEY DO NOT RECALL ANY SIGNIFICANT EVENTS THAT LED TO THE ALARM OR IF THE DEVICE WAS DROPPED. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 206 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 713144 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-722NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |