FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 3093726
·
Received May 6, 2013
Report
- Report Number
- 2032227-2013-01670
- Event Type
- Malfunction
- Date Received
- May 6, 2013
- Date of Event
- April 2, 2013
- Report Date
- April 9, 2013
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS RECEIVED WITH LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP WAS RECEIVED WITH A SCRATCHED LCD WINDOW.
Description of Event or Problem · 1
CUSTOMER'S MOTHER REPORTED THAT THE DRIVE SUPPORT CAP IS PROTRUDED. SHE NOTICED THE PROTRUDING ABOUT ONE WEEK AGO. CUSTOMER PUSHED THE DRIVE SUPPORT CAP IN. AFTER READING THE FIELD NOTIFICATION LETTER, CALLER WANTS THE INSULIN PUMP REPLACED. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 196630 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-722LNAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |