FDA Adverse Event
Injury
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 3251030
·
Received July 29, 2013
Report
- Report Number
- 3004209178-2013-96131
- Event Type
- Injury
- Date Received
- July 29, 2013
- Date of Event
- February 12, 2013
- Report Date
- July 20, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED NO DELIVERY OUTSIDE OF SPECIFICATION RANGE DUE TO A FAULTY FORCE SENSOR. THE BOLUS WIZARD WAS FUNCTIONING PROPERLY, AND THE MINILINK TRANSMITTER COMMUNICATES PROPERLY TO THE INSULIN PUMP. THE CALCULATIONS WERE DOWNLOADING PROPERLY TO THE DEVICE.
Description of Event or Problem · 1
A PHONE CALL WAS CONDUCTED IN ORDER TO FOLLOW UP ON A PREVIOUS CALL THAT THE CUSTOMER MADE FOR LOW BLOOD GLUCOSE, AND FOUND THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 28MG/DL. TROUBLESHOOTING WAS NOT PERFORMED AT THAT TIME AS THE NURSE FELT THAT THE INSULIN PUMP WAS CALCULATING THE BOLUSES INCORRECTLY. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 353620 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-722NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization |