FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 4153731
·
Received October 8, 2014
Report
- Report Number
- 2032227-2014-24900
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- August 22, 2014
- Report Date
- September 9, 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
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS RECEIVED WITH CRACKED AND BLEEDING DISPLAY GLASS AND MINOR SCRATCHES ON THE DISPLAY WINDOW.
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
THE CUSTOMER REPORTED THAT HE WAS UNABLE TO READ THE SCREEN OF THE INSULIN PUMP, AFTER BUMPING INTO THE MARBLE BATHROOM SINK AND A BLACK SPOT ON THE SCREEN APPEARED. THE CUSTOMER'S BLOOD GLUCOSE WAS NOT KNOWN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631800 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-751NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |