FDA Adverse Event
Injury
Summary report: N
530G INSULIN PUMP
MDR report key: 4141685
·
Received October 4, 2014
Report
- Report Number
- 2032227-2014-33283
- Event Type
- Injury
- Date Received
- October 4, 2014
- Date of Event
- September 4, 2014
- Report Date
- September 4, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 500 MG/DL. CUSTOMER STATED THAT SHE HAS HAD REALLY HIGH BLOOD SUGARS AND THE PREVIOUS SET SHE CHANGED HAD A BENT CANNULA. CUSTOMER STATED THAT SHE HAD HIGH BLOOD GLUCOSE LEVELS ALL DAY. CUSTOMER STATED THAT SHE WILL CALL BACK TONIGHT TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVELS. NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 621028 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-551NAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |