FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 2871821
·
Received December 13, 2012
Report
- Report Number
- 3004209178-2012-91346
- Event Type
- Malfunction
- Date Received
- December 13, 2012
- Date of Event
- September 16, 2012
- Report Date
- December 5, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH MOTOR ERROR ALARM DURING THE BASIC OCCLUSION TEST, AND THE DEVICE ALARMED DURING THE PRIME TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER HAD ISSUES DURING PRIME/REWIND. THE BLOOD GLUCOSE READING WAS 150MG/DL. IT WAS STATED THAT THE INSULIN PUMP ALARMED DURING THE MANUAL PRIME PROCESS. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. 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 |