FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 4201130
·
Received October 27, 2014
Report
- Report Number
- 2032227-2014-42884
- Event Type
- Malfunction
- Date Received
- October 27, 2014
- Date of Event
- September 25, 2014
- Report Date
- September 26, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
INSULIN PUMP PASSED DISPLACEMENT TEST. HOWEVER, INSULIN PUMP ALARMED PRIME DURING BASIC OCCLUSION TEST, DUE TO SLIGHTLY LOOSE DRIVE SUPPORT DISK. INSULIN RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW, BROKEN BELT CLIP SLOT AND CRACKED CASE ON DISPLAY WINDOW CORNERS.
Additional Manufacturer Narrative · 1
CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT THERE IS AN ALARMING INSULIN PUMP. THE BLOOD GLUCOSE READING IS 350 MG/DL. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 682223 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-722NAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |