FDA Adverse Event
Malfunction
Summary report: N
VIDAS INSTRUMENT
MDR report key: 586124
·
Received March 23, 2005
Report
- Report Number
- 3002769706-2005-00010
- Event Type
- Malfunction
- Date Received
- March 23, 2005
- Date of Event
- March 4, 2005
- Report Date
- March 23, 2005
- Manufacturer
- BIOMERIEUX, INC.
- Product Code
- JZT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE VIDAS INSTRUMENT IS A DISCRETE WAVELENGTH FLUOROMETER. THE INSTRUMENT HAS 5 SECTIONS WITH 6 POSITIONS PER SECTION. THE POSITIONS OPERATE MECHANICALLY INDEPENDENT OF EACH OTHER AND EACH POSITION CONTAINS A SAMPLE. THE CUSTOMER REPORTED ONE POSITION TO BE OUT OF RANGE WHEN A QUALITY CONTROL TEST WAS RUN. THE CUSTOMER THEN DISCOVERED THAT ONE VIDAS H. PYLORI ASSAY RESULT PRODUCED A FALSE NEGATIVE. THE VIDAS H. PYLORI ASSAY IS AN ASSAY FOR THE DETECTION OF IGC ANTIBODIES TO HELICOBACTER PYLORI. THIS FALSE RESULT WAS REPORTED TO THE PHYSICIAN. HOWEVER, NO ADVERSE EFFECTS ON TREATMENT OF THE PT OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIDAS INSTRUMENT | DISCRETE WAVELENGTH FLUOROMETER | JZT | BIOMERIEUX, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |