FDA Adverse Event
Injury
Summary report: N
RESERVOIR 3ML
MDR report key: 3123013
·
Received May 21, 2013
Report
- Report Number
- 3004209178-2013-93803
- Event Type
- Injury
- Date Received
- May 21, 2013
- Date of Event
- March 30, 2013
- Report Date
- April 30, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- FRN
- PMA / PMN Number
- K032005
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
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. PLEASE SEE MDR # 203227-2013-01899.
Description of Event or Problem · 1
CUSTOMER'S MOTHER'S (B)(6) CALLED TO REPORT A HOSPITALIZATION DUE TO DIABETIC KETOACIDOSIS. THE CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS OVER 700 MG/DL. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224562 | RESERVOIR 3ML | RESERVOIR | FRN | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-332A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Hospitalization |