FDA Adverse Event
Malfunction
Summary report: N
PARADIGM INSULIN INFUSION PUMP
MDR report key: 2830859
·
Received November 13, 2012
Report
- Report Number
- 3004209178-2012-90718
- Event Type
- Malfunction
- Date Received
- November 13, 2012
- Date of Event
- August 19, 2012
- Report Date
- November 7, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LZG
- PMA / PMN Number
- K040676
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. THE DEVICE HAD A BROKEN RESERVOIR TUBE LIP.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT HER INSULIN PUMP ALARMED DURING THE MANUAL PRIME PROCESS. ADVISED THE CUSTOMER REVERT TO BACK UP PLAN. THE BLOOD GLUCOSE READING WAS 170MG/DL. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM INSULIN INFUSION PUMP | LZG | LZG | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-715NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |