MalfunctionJZT
VIDAS
Received Jun 28, 2001 · Event occurred Jun 13, 2001
Report 1950204-2001-00010 · MDR key 340537
Device
Generic name
Immunoflurometric Equipment
Manufacturer
Biomerieux, Inc.Model number
VIDAS 30Catalog number
W2010
Lot number
NA
Product problems
- False Negative Result
- False Positive Result
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
CUSTOMER CONTACTED THE COMPANY WITH A SINGLE INCORRECT ASSAY RESULT. FURTHER INVESTIGATION REVEALED THAT POSITION D4 GAVE FOUR FALSE RESULTS, TWO FALSE POSITIVES, TWO FALSE NEGATIVES. NO FALSE RESULTS WERE REPORTED TO THE PT AS ALL FALSE RESULTS WERE DETECTED BY RETEST PRIOR TO REPORTING RESULTS.
Remedial action
- Inspection
- Notification
- Repair