FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 3081811
·
Received April 29, 2013
Report
- Report Number
- 3004209178-2013-92904
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Date of Event
- April 6, 2013
- Report Date
- April 6, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNABLE TO PERFORM THE OCCLUSION, EXCESSIVE NO DELIVERY ALARM TESTS DUE TO PRIME FILL ANOMALY. UNIT HAD MISSING END CAP STICKER. HOWEVER, UNIT PASSED THE DISPLACEMENT TEST.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE INSULIN PUMP DRIVE SUPPORT CAP IS STICKING OUT. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185007 | 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 | 41 YR |