FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 2802133
·
Received October 23, 2012
Report
- Report Number
- 3004209178-2012-90310
- Event Type
- Malfunction
- Date Received
- October 23, 2012
- Date of Event
- September 12, 2012
- Report Date
- October 15, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. THE DEVICE REWINDS PROPERLY.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT HIS INSULIN PUMP ALARMED AN ERROR. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ABLE TO REWIND THE DEVICE, BUT IT DID ALARM DURING THE PRIME PROCESS. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | OYC | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-722NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR |