FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 4213353
·
Received October 25, 2014
Report
- Report Number
- 2032227-2014-43326
- Event Type
- Malfunction
- Date Received
- October 25, 2014
- Date of Event
- September 5, 2014
- Report Date
- September 26, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- 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
CUSTOMER REPORTED RECEIVING A BLANK DISPLAY ON HIS INSULIN PUMP. THE CUSTOMER WAS ASSISTED WITH PEN-PRIMING THE INSULIN PUMP. THE INSULIN PUMP ALSO PASSED A SELF TEST DURING TROUBLESHOOTING. THE CUSTOMER WAS ADVISED A BLANK DISPLAY MAY BE CAUSED BY ELECTROSTATIC DISCHARGE. NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 680753 | 530G INSULIN PUMP | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-751NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |