FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 4183496
·
Received October 18, 2014
Report
- Report Number
- 2032227-2014-40230
- Event Type
- Malfunction
- Date Received
- October 18, 2014
- Date of Event
- September 19, 2014
- Report Date
- September 20, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).
Description of Event or Problem · 1
NO BLOOD GLUCOSE LEVELS REPORTED. THE CUSTOMER REPORTED THAT THE VIBRATE ALARM WAS GOING OFF WHEN EVEN IF IT WAS NOT SUPPOSED TO. THE ALARM HISTORY OF THE INSULIN PUMP DOES NOT SHOW ANY ALARMS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663938 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-751NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |