FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 2984112
·
Received February 28, 2013
Report
- Report Number
- 3004209178-2013-91496
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- November 10, 2012
- Report Date
- February 22, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION 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 6.3MMOL/L. IT WAS STATED THAT INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS AND THEN THE DEVICE ALARMED. IT WAS MENTIONED THAT THE INSULIN PUMP WAS STUCK ON THE PRIME LOOP. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88141 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-522WWP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |