FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 4252160
·
Received November 14, 2014
Report
- Report Number
- 2032227-2014-52918
- Event Type
- Malfunction
- Date Received
- November 14, 2014
- Date of Event
- October 18, 2014
- Report Date
- October 18, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS DUE TO LIGHT MOISTURE DAMAGE TO THE KEYPAD TRACES. NO BUTTON ERROR ALARM WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW.
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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER'S SPOUSE, THAT THE BUTTONS ON THE INSULIN PUMP ARE UNRESPONSIVE. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 237MG/DL. TROUBLESHOOTING OCCURRED. ADVISED INSULIN PUMP WOULD BE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 738413 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-751NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |