FDA Adverse Event
Injury
Summary report: N
530G INSULIN PUMP
MDR report key: 3882440
·
Received June 18, 2014
Report
- Report Number
- 3004209178-2014-85914
- Event Type
- Injury
- Date Received
- June 18, 2014
- Date of Event
- May 16, 2014
- Report Date
- May 31, 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
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
CUSTOMER REPORTED HE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. HE STATED THAT THE HIGH BLOOD GLUCOSE READING AT THE TIME OF THE HOSPITALIZATION WAS 817MG/DL. NOTHING FURTHER TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 357537 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-751NAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization |