FDA Adverse Event
Malfunction
Summary report: N
INSULIN INFUSION PUMP
MDR report key: 3093729
·
Received May 6, 2013
Report
- Report Number
- 2032227-2013-01673
- Event Type
- Malfunction
- Date Received
- May 6, 2013
- Date of Event
- April 9, 2013
- Report Date
- April 9, 2013
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- Product Problem
- 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 RESPONDING TO THE FIELD NOTIFICATION LETTER. CUSTOMER STATED THAT THE DRIVE SUPPORT DISK IS STICKING OUT AND HAS RECEIVED NO DELIVERY ALARMS. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 196631 | INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-XXX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |