FDA Adverse Event
Malfunction
Summary report: N
INSULIN INFUSION PUMP
MDR report key: 4822983
·
Received June 6, 2015
Report
- Report Number
- 2032227-2015-18111
- Event Type
- Malfunction
- Date Received
- June 6, 2015
- Date of Event
- March 19, 2015
- Report Date
- May 19, 2015
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV
- 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 VIA PHONE CALL THAT THE INSULIN PUMP IS HAVING TROUBLE PUSHING OUT INSULIN THROUGH THE RESERVOIR. THE BLOOD GLUCOSE READING IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 366717 | INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-XXX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |