FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 2924725
·
Received January 22, 2013
Report
- Report Number
- 3004209178-2013-90480
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Date of Event
- December 25, 2012
- Report Date
- January 14, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH CURRENTS WITHIN SPECIFICATIONS. HOWEVER, THE DEVICE WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. THE MOTOR PASSED THE MOTOR TEST.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE BOLUS DELIVERY. THE BLOOD GLUCOSE READING WAS 178MG/DL. TROUBLESHOOTING WAS PERFORMED. ASSISTED THE CALLER TO RUN THE SELF AND DISPLACEMENT TEST AND THEY PASSED. REVIEWED THE ALARM HISTORY AND FOUND MOTOR ERROR, NO DELIVERY, AND AUTO OFF ALARMS. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28899 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-722NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |