FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 4233676
·
Received November 6, 2014
Report
- Report Number
- 2032227-2014-48983
- Event Type
- Malfunction
- Date Received
- November 6, 2014
- Date of Event
- October 3, 2014
- Report Date
- October 10, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW, A SCRATCHED CASE AND CRACKED AND BLEEDING DISPLAY GLASS WERE NOTED DURING THE VISUAL INSPECTION.
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 MOTHER SARAH, THAT THE CUSTOMER'S INSULIN PUMP HAS A CRACK ON THE DISPLAY SCREEN. TROUBLESHOOTING OCCURED. ADVISED INSULIN PUMP WOULD BE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715511 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-551NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR |