FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 4192975
·
Received October 22, 2014
Report
- Report Number
- 2032227-2014-41651
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Date of Event
- February 8, 2014
- Report Date
- March 12, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP OPERATING CURRENTS ARE WITHIN THE SPECIFICATION, NO UNEXPECTED LOW BATTERY, OFF NO POWER, FAILED BATTERY TEST OR WEAK BATTERY ALARM NOTED, HOWEVER BATTERY TUBE WAS CORRODED. NO BANK DISPLAY OR DAMAGE INSIDE PUMP NOTED. PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP.(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS ALARMING FAILED BATTERY AND THE DAMAGED. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER STATED THEY DO NOT RECALL ANY SIGNIFICANT EVENTS THAT LED TO THE ALARM OR IF THE DEVICE WAS DROPPED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 138 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 672431 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-751NAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |