FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 3984387
·
Received August 6, 2014
Report
- Report Number
- 3004209178-2014-90524
- Event Type
- Malfunction
- Date Received
- August 6, 2014
- Date of Event
- July 6, 2014
- Report Date
- July 6, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- OTHER
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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE KEYPAD OF THE INSULIN PUMP IS UNRESPONSIVE. CUSTOMER STATED THAT SHE JUMPED INTO THE POOL WITH THE INSULIN PUMP. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 321 MG/DL. NO FURTHER INFORMATION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 461905 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-751NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |