FDA Adverse Event
Malfunction
Summary report: N
VIDAS
MDR report key: 335405
·
Received May 24, 2001
Report
- Report Number
- 1950204-2001-00008
- Event Type
- Malfunction
- Date Received
- May 24, 2001
- Date of Event
- March 21, 2001
- Report Date
- May 22, 2001
- Manufacturer
- BIOMERIEUX INC.
- Product Code
- JZT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE AS PART OF A WORLDWIDE CHECK FOR CLOGGED PUMP TUBES ON THE VIDAS INSTRUMENT. DURING ONE SUCH VISIT TO THE CUSTOMER BELOW BY BIOMERIEUX FIELD SERVICE ENGINEER THE INSTRUMENT FAILED PERFORMANCE TESTING WHICH INDICATED THAT THE PUMP IN THE FAILING POSITION COULD BE CLOGGED. THE PUMP WAS FURTHER ANALYZED AND IT WAS DETERMINED THAT IT WAS CLOGGED. A CLOGGED PUMP TUBE CAN RESULT IN INACCURATE TEST RESULTS BEING REPORTED BY THE LABORATORY. THE PUMP WAS REPLACED BY THE FIELD SERVICE ENGINEER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24218 | VIDAS | IMMUNOFLUROMETRIC EQUIPMENT | JZT | BIOMERIEUX INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |