FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 3093713
·
Received May 6, 2013
Report
- Report Number
- 2032227-2013-01666
- 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
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 REGARDING THE FIELD NOTIFICATION LETTER. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED, HE PUSHED IT BACK IN. ADVISED CUSTOMER NOT TO MANIPULATE OR PUSH THE DRIVE SUPPORT CAP WHILE CONNECTED. ADVISED CUSTOMER THAT THE INSULIN PUMP MUST BE REPLACED. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 196143 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-722LNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR |