FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 4142247
·
Received October 5, 2014
Report
- Report Number
- 2032227-2014-33371
- Event Type
- Malfunction
- Date Received
- October 5, 2014
- Date of Event
- September 5, 2014
- Report Date
- September 5, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP.
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
IT WAS REPORTED THAT THE TWO-YEAR-OLD PATIENT ONCE GAVE HERSELF INSULIN FROM THE INSULIN PUMP ON HER OWN. IT WAS STATED THAT NORMALLY THE KEYPAD IS LOCKED. AT THE TIME OF THE REPORT, THE PATIENT'S BLOOD GLUCOSE WAS 425 MG/DL. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 621902 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-551NAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 MO |