FDA Adverse Event
Injury
Summary report: N
INSULIN INFUSION PUMP
MDR report key: 3231386
·
Received July 17, 2013
Report
- Report Number
- 2032227-2013-02985
- Event Type
- Injury
- Date Received
- July 17, 2013
- Date of Event
- June 19, 2013
- Report Date
- June 19, 2013
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- 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 CALLED TO REPORT REDNESS AND ITCHING AT INSERTION SITE. THE BLOOD GLUCOSE READING 334 MG/DL. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED IF AMBULANCE SHOULD BE DISPATCHED. CUSTOMER STATED THAT SHE WOULD DRIVE HERSELF TO HOSPITAL. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330943 | INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-XXX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Hospitalization |